Supported by The Lourie Foundation, Inc.

Ethics Statement: Stony Brook University Institutional Review Board (IRB) approved this protocol on February 10, 2015.
1. Recruitment of Participants for Remotely-Supervised tDCS
<ol>
	<li>Provide recruited study participants with information on the device and the ten day study protocol.</li>
</ol>
2. Inclusion/Exclusion Criteria
<ol>
	<li>Health
	<ol>
		<li>Ensure that a clinician has provided medical clearance for all enrolled participants at the baseline visit.</li>
	</ol>
	</li>
	<li>tDCS tolerability and laptop aptitude
	<ol>
		<li>Ensure that participants are familiar with the basic functioning of a laptop computer and how to connect the computer to Wi-Fi internet. For both the use of the laptop, and the setup of the tDCS device, ensure that participants (or a proxy), have the dexterity to complete the procedures.</li>
		<li>Beyond setup, at baseline visits, give participants a 1 min trial dose of 1.5 mA of tDCS to determine tolerability. If participants cannot tolerate this session, a lower dose of 1.0 mA can be applied. If neither is tolerated, exclude the participant.</li>
	</ol>
	</li>
	<li>Environmental
	<ol>
		<li>Confirm that participants have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit.</li>
	</ol>
	</li>
	<li>Compliance
	<ol>
		<li>If a participant does not adhere to the scheduled video conference session in a timely fashion, exclude that participant.</li>
	</ol>
	</li>
	<li>Stop Criteria
	<ol>
		<li>At each participant interaction, review a series of predetermined &#34;stop criteria&#34; to ensure that participants tolerate the session, adhere to the study schedule, and safely operate the device without adverse effects. Should any of these be met, exclude the participant from the study (Figure 1).</li>
	</ol>
	</li>
</ol>
3. Materials
Note: As recommended in the published guidelines for remotely-supervised use16, precise electrode preparation and placement must mirror the clinic protocol with respect to dose control and ongoing monitoring.
<ol>
	<li>Device Kit
	<ol>
		<li>Prepare the same materials for every remote tDCS participant. This includes a study provided laptop computer with secure video conferencing software, the device, and a device kit.</li>
		<li>Design the device kit for ease of use and organize it by day (Figure 2).</li>
		<li>Prepare the kit with twenty wrapped sponge pockets of size 5x5cm with a perforation at the top (two per day required for a 10-day study) , twenty syringes pre-filled with 6 mL of saline solution for each sponge pocket, a wash bottle filled with extra saline, spare batteries for the device, and a handheld mirror for headset application.</li>
		<li>In addition, require that study users have a portable home phone or mobile phone at their workspace for each session.</li>
	</ol>
	</li>
	<li>Device
	<ol>
		<li>Choose a tDCS device that only releases a session through a one-time use unlock code. Ensure that the study device has functionality whereby participants can only administer a session after being provided the code by the study technician. In addition, ensure that in the selection of a study device, contact quality is continually monitored to ensure safe and proper use.</li>
	</ol>
	</li>
	<li>Video Monitoring
	<ol>
		<li>Choose a secure video conferencing software to allow for remote supervision of the proper setup of the device, optimal contact quality, and that the intended user is applying the session.</li>
		<li>Use the video conferencing software as another method of training. Instruct users how to turn the device on, read their contact quality, troubleshoot poor contact quality, enter a one-time use unlock code, and safely remove the device after shutdown.</li>
	</ol>
	</li>
	<li>Headgear
	<ol>
		<li>Design the headgear for simple and robust electrode positioning. Use a single-position headgear to eliminate room for user error, and to help conserve the placement of the montage. Configure a cap-like design, with clearly labeled sponge markers to enhance the reliability of placement in the single-position headgear with the anodal electrode placed on the left side.</li>
	</ol>
	</li>
</ol>
4. Training
Note: Complete the majority of participant training during the first baseline session of the remote study. Roughly 1-2 hr of the baseline visit should be spent on training. Allow participants to view an instructional tDCS video as their first instruction.
<ol>
	<li>Instructional video
	<ol>
		<li>Set up the instructional video to play for the participant following the baseline visit. During the viewing, allow the participant to have access to the device and device kit and to follow along at each step.</li>
		<li>Prepare the video to first introduce the participant to the materials and then transition into a step-by-step guide that mimics the flow of an actual study session.</li>
		<li>Present the setup of the tDCS headset slowly and clearly (and make it available for replay), should the user need clarification. Also provide a participant view so that the study participant can gain a sense of what device screens to expect and how the device display will appear when providing certain readings.</li>
	</ol>
	</li>
	<li>Video sections 
	Note: Remote technicians will not provide unlock codes for devices unless appropriate contact quality is achieved.
	<ol>
		<li>Design the instructional video to detail the means of troubleshooting poor contact quality, including applying pressure and moistening the sponge pockets. Ensure that the video also provides information on the safe usage of study materials, as well as the protocol to follow in order to end a session.</li>
		<li>Instruct participants on procedures to terminate a session and require participants to maintain phone access throughout the duration of the session, ensuring that a level of in-clinic safety is maintained in the case of emergency,</li>
		<li>Following the video, allow the participant to attempt their own set up with the aid of a study technician.</li>
	</ol>
	</li>
	<li>Instruction manual
	<ol>
		<li>Prepare a transcript of the information presented in the video, as well as photographs and diagrams of the materials, device screenshots, and laptop information, in the form of a manual.</li>
	</ol>
	</li>
	<li>In-person training
	<ol>
		<li>Monitor the participant as they begin the set-up.</li>
		<li>Coach the participant through each step (moisten sponge pockets, insert electrode into the sponge, fasten sponges on to the headset, place headset on head, center the headset, confirm with study technician, and turn device on).</li>
		<li>Clarify the procedure or equipment where necessary.</li>
	</ol>
	</li>
	<li>Troubleshooting for participants that experience setup difficulty
	<ol>
		<li>If participants struggle with the set-up, repeat the demonstration of the method.</li>
		<li>If participants are unable to complete the set up after repeated attempts, terminate the session. This is defined as a study &#34;stop&#34; criteria.</li>
	</ol>
	</li>
</ol>
5. Participant Preparation for Study Session
<ol>
	<li>Instruct participants to set up their study laptop, mobile phone, device kit, device and headset in a clean, well lit area. Inform participants to pull hair back and minimize distractions.</li>
	<li>Allow participants to refer to the instructional video or manual for a step by step guide of the protocol.</li>
	<li>First initiate web conference with the study participant before beginning setup so that there is ongoing monitoring for compliance16.</li>
</ol>
6. Device Setup during Study Session
<ol>
	<li>After the video conference is initiated, instruct the participant to begin set up.</li>
	<li>Open the sponge pockets and moisten using the 6 mL syringes (one syringe per sponge pocket). About 3 mL can be used to moisten each side of the sponge pocket.</li>
	<li>Apply carbon-rubber electrodes to carry current from the tDCS stimulator. Encase the electrodes in sponge pockets. Insert each carbon rubber electrode into the sponge pocket fully. Note: Since direct skin contact with rubber electrodes is painful, electrodes are encased in sponge pockets.</li>
	<li>Ensure the red cable is connected to red receiver plug labeled &#39;anode&#39; on the device. Ensure the black cable is connected to black receiver plug labeled &#39;cathode&#39; on the device. These cables are never removed from the device.</li>
	<li>Connect the sponge pockets and electrodes to the headset using the common bilateral dorsolateral prefrontal cortex (DLPC), with the anodal electrode (one connected to the red wire) placed on the left side. Note: Label the headset with red and black to ensure proper electrode placement.</li>
	<li>Fasten the headset using buttons on the sponge pockets that fit into grooves on the headset. The smooth side of the sponge pocket always faces in toward the forehead. 
	Note: This offers ease of reliable electrode placement and wide therapeutic applications.</li>
	<li>After the sponge pockets are fastened, position the headset on the head. Tuck the back strap beneath the groove in the back of the head and align the center button with the nasion. This can be confirmed using the handheld mirror supplied in the device kit and by the study technician through video conferencing software.</li>
	<li>At this point, instruct the participant to read aloud the contact quality on the device display. Note: A moderate or optimal reading is required for session code administration.</li>
	<li>If contact quality needs to be improved, instruct participants to follow pre-set troubleshooting procedures. First, recommend applying pressure to the sponge pockets. If this does not prove successful, give participants the option to apply a small amount of saline solution to the sponge pockets using the wash bottle (paper towels are provided for any spillage).</li>
	<li>Once proper contact quality is achieved, administer a one-time use unlock code for the sessions. Note: These codes are pre-programmed by study staff for the set amount of time and amplitude.</li>
</ol>
7. Session completion
Note: After the participant enters the unlock code, the screen of the device will show a timer that counts down the minutes until the end of the session. The device will also indicate the contact quality of the electrodes throughout the session. When 1 min remains on the timer, a countdown in seconds will occur.
<ol>
	<li>If contact quality falls below &#34;moderate&#34; provide instructions on how to improve it using the troubleshooting steps in 6.9.</li>
	<li>Remind the participant to not to remove the headset until the seconds have fully counted down to zero and the device shuts off (confirmed with a beeping noise).</li>
	<li>Instruct the participant to remove the headset when the device beeps.</li>
	<li>Direct the participant to remove sponge pockets from the device and discard them. Syringes are one time use as well and should also be discarded.</li>
	<li>Ensure that the participant stores the device and headset in the kit.</li>
	<li>Remind the participant to safely store the laptop, device, and all materials for the next session.</li>
</ol>
8. End of Study Analyses
<ol>
	<li>Assess each study participant using a participant tracker. This serves as a method of recording study compliance, adverse events, and session completion. At the end of study, review each participant&#39;s data to determine study success. For the purpose of this protocol, study success will be defined by 80% of participants having completed 80% of study sessions24.</li>
	<li>Validate session success through records of daily session attendance, review of daily pain scales and before and after stimulation questionnaires for adverse events Please see Supplemental Code Files for sample questionnaire. 
	Note: Validation that the 20 min&#160;of stimulation were fully delivered can be reviewed at study end. The study technician can access the device for completion codes as confirmation.</li>
</ol>

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E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Remotely-supervised+transcranial+direct+current+stimulation+(tDCS)+for+clinical+trials:+guidelines+for+technology+and+protocols.">Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.</a> Frontiers in systems neuroscience. 9, 26 (2015).</li><li>Palm, U., Ayache, S. S., Padberg, F., Lefaucheur, J. 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CUNY has patents with Marom Bikson as inventor. Marom Bikson has equity in Soterix Medical Inc. CUNY has patents with Abhishek Datta as inventor. Abhishek Datta has equity in Soterix Medical Inc.

Critical steps within the protocol 
As remotely-supervised tDCS is administered away from the direct supervision of a clinician, inclusion and exclusion criteria are designed to ensure that the participant has no contraindicated health conditions or environmental distractions, and are fully capable to use a laptop computer (including those with adaptive technology) for communication with the research team. In addition, participants must be able to tolerate a tDCS session and commit to the scheduled session time for the duration of the study.
While remote tDCS offers a convenience to the study and administration of the therapy, self-directed participant use is not advisable due to both safety concerns and the inability to monitor and standardize the stimulation that is delivered. Instead, our protocol follows the standards and guidelines for remotely-supervised tDCS16 to extend clinic standards through delivery in a remote location. The guidelines ensure that research staff are properly trained for participant interactions, that users have proper ability to participate in remote tDCS, and that there are ongoing training materials as well as assessments made of the participant at each step of the study. The stimulation was uniform and reproducible with exactly 20 min&#160;of 1.5 mA delivered at every session without any interruption or variation across sessions or individuals.
Modifications to the protocol and troubleshooting tips
The protocol includes several small modifications. Firstly, we expanded the use of this protocol to MS participants that have an EDSS score above 6.5 in the instance where there is a proxy accessible to administer each dose. In addition, we have implemented a procedure whereby we remotely access the participant&#39;s study provided laptop to initiate the web conference for those who need extra support and review measures of tolerability and study experiences through a shared document. A future modification to the current protocol includes allowing various degrees of remote supervision so that participants who prove most competent with the technique would only require early supervision to confirm device set up and to receive the unlock code.
Limitations of the technique 
While our preliminary results support the feasibility of this protocol, the sample size is limited. As enrollment expands, analyses will be made for gaps in training, ways to streamline sessions, enhance the instructional video, and make the technique more accessible to those with motor impairment (i.e., adaptive mice for computer usage, sponge pocket/headset modification to further ease application). Some participants in the EDSS range below 6.5 (not requiring proxy), may still experience some difficulty in headset preparation and troubleshooting computer related issues. Furthermore, while this study recommends full remote monitoring of participants throughout all sessions, future studies may deem some participants sufficiently trained to operate the device without supervision for the entirety of a session.
Significance of the method with respect to existing methods 
These initial results demonstrate the feasibility of our protocol for remotely-supervised tDCS delivery for clinical trials, following a set of guidelines and standards that must be employed to safely, and effectively administer tDCS under remote supervision. The protocol was designed to have a decision-tree series of checkpoints with &#34;stop&#34; criteria (section 2.5.1 above) that must be cleared in order to proceed at each step (see Figure 1). These checkpoints addressed tolerability (experiences of pain or adverse effects to the treatment) and compliance (timely session attendance and proper technique). For each session 1 through 10, participants completed brief adverse event reports before and after their sessions (with items derived from a list of the most common tDCS side-effects in previous trials). In addition, participants completed the self-report measures to address tolerability (before and after the session) and can complete symptom inventories as well. This study is significant in that it establishes a technique to examine a therapy in MS with adequate power while also providing broader access to tDCS treatment.
Future applications of the technique
Once the method for remotely-supervised tDCS has been fully piloted in the MS population, a larger, randomized controlled trial can be initiated to target symptom management. Through the use of the instructional training materials and structure around daily participant interactions, remotely-supervised tDCS can be accessed by a wider range of patient populations and expand clinical study of the technique.

tDCS is a relatively recent therapy that operates through the use of low amplitude (2.0 mA or less) direct current to modulate cortical excitability 1. Hundreds of clinical trials have demonstrated tDCS to be safe and well-tolerated2-4. tDCS is easier to use, lower in cost, and better tolerated when compared to other methods such as transcranial magnetic stimulation (e.g., tDCS has not been associated with the development of seizures 5,6). Multiple tDCS sessions are required for benefit, especially when administered with the goal of enhancing rehabilitation outcomes.7-10
It is not yet known how many tDCS sessions are necessary or optimal, but the effects are cumulative with little evidence that tDCS over a single session produces behaviorally meaningful changes.2,11 For example, studies of depression have found 30 or more sessions needed for full benefit in some participants. 12,13 Multiple sessions are especially important when pairing tDCS with a behavioral therapy, which only occurs with rigorous repetition across many sessions. 14
For many patients and caregivers, traveling to the outpatient facility to receive repeated tDCS treatment sessions is a major obstacle in terms of time, cost and travel arrangements. This real-world limitation has resulted in studies with small sample sizes and without adequate power or design to draw conclusions that can lead to clinical use.15 Remote tDCS delivery would allow for participation in study protocols from home or other locations, and reach those patients who otherwise would not have access to these trials. Further, it allows the possibility for testing "on-demand" application for indications such as epilepsy and migraines. 
We have worked with a diverse group of clinical investigators interested in remotely-supervised tDCS to develop guidelines and standards for remotely-supervised tDCS delivery including specialized equipment and specific training requirements both for staff and study participants16. Here, we developed a protocol to follow these guidelines and test for feasibility in patients with multiple sclerosis (MS), a disorder where tDCS may be a useful tool for the management of its symptoms. 11,17-23

<table><tbody><tr><td>Mini-CT transcranial direct current stimulation device</td><td>Soterix</td><td></td><td>Device to deliver direct current stimultion in a remote manner</td></tr><tr><td>Study Kit&amp;nbsp;</td><td></td><td></td><td>Provided to participant with all required setup items - device, headset, sponge pockets, pre-filled syringes, Kleenex, handheld mirro, spare batteries&amp;nbsp;</td></tr><tr><td>Laptop&amp;nbsp;</td><td></td><td></td><td>Provided to allow secure video conferecing during device setup and headset placement</td></tr><tr><td>Instruction Manual&amp;nbsp;</td><td></td><td></td><td>Transcription of instructional video and detailed instructions for protocol&amp;nbsp;</td></tr></tbody></table>

a protocol for the use of remotely-supervised transcranial direct current stimulation (tdcs) in multiple sclerosis (ms)

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low amplitude direct currents to alter cortical excitability. With well-established safety and tolerability, tDCS has been found to have the potential to ameliorate symptoms such as depression and pain in a range of conditions as well as to enhance outcomes of cognitive and physical training. However, effects are cumulative, requiring treatments that can span weeks or months and frequent, repeated visits to the clinic. The cost in terms of time and travel is often prohibitive for many participants, and ultimately limits real-world access. 
Following guidelines for remote tDCS application, we propose a protocol that would allow remote (in-home) participation that uses specially-designed devices for supervised use with materials modified for patient use, and real-time monitoring through a telemedicine video conferencing platform. We have developed structured training procedures and clear, detailed instructional materials to allow for self- or proxy-administration while supervised remotely in real-time. The protocol is designed to have a series of checkpoints, addressing attendance and tolerability of the session, to be met in order to continue to the next step. The feasibility of this protocol was then piloted for clinical use in an open label study of remotely-supervised tDCS in multiple sclerosis (MS). This protocol can be widely used for clinical study of tDCS.

We have adapted this protocol for use in MS. We targeted the delivery of ten tDCS stimulation sessions delivered over two weeks. 9,10 The first two sessions of the ten were in-person training sessions and the following eight were remotely supervised (Figure 3). The second session consists of an environmental suitability assessment where study technicians visited the participant&#39;s home to confirm appropriate set-up.
To complete the following remotely-supervised sessions, participants were provided with the tDCS device specially-designed for remote use and a headset that was modified for ease of use to guide accurate electrode placement. A device kit was provided and included the device and headset, one-time use sponge pockets for electrodes and syringes filled with the measured amount of saline required for each sponge, with all items individually labeled by day and organized for ease of use. Electrodes were placed in the bilateral dorsolateral prefrontal cortex (DLPC) position with the anodal electrode placed on the left side. 10 This offers ease of reliable electrode placement, wide therapeutic applications.9,10 Based on prior studies we targeted 1.5 mA for 20 min&#160;sessions. The protocol 9,10allowed for a current reduction to 1.0 mA at baseline if this improves overall subject tolerability.
Participants were given a study-provided laptop computer configured for the study, including the easily accessible instructional video and link for secure video conference connection with the study technician. The laptop also included a program for remote monitoring of all computer activity, and a program to remotely access the computer for technical support. Detailed manuals for operation were used by both the participant and study technician, and a binder for self-report measures was provided.
A total of n=20 MS participants have completed the study. Inclusion criteria specified an Expanded Disability Status Scale (EDSS)25 * of 6.0 or below OR 6.5 or above with proxy to ensure minimal motor requirements to operate the device. Enrollment has been representative of a range of impairment in MS (motor impairment, cognitive impairment, or both). All 20 participants, n=4 with proxy, were successfully trained to self-apply a tDCS session and 192 total sessions were completed. As shown in Figure 4, 40 of the192 sessions included training; the remaining 152 were exclusively remotely-supervised sessions. Of the remotely-supervised sessions, 100% were executed correctly with successfully placement of electrodes, device operation and well-tolerated delivery of stimulation.
<img alt="Figure 1" src="/files/ftp_upload/53542/53542fig1.jpg" /> 
Figure 1.&#160;Stop Criteria Flowchart. The chart details the various criteria that indicate a participant can no longer proceed or participate in a remotely-supervised tDCS study. <a href="https://www-jove-com.remotexs.ntu.edu.sg/files/ftp_upload/53542/53542fig1large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 2" src="/files/ftp_upload/53542/53542fig2.jpg" /> 
Figure 2.&#160;Device Kit.&#160;This view demonstrates the device kit with individually wrapped sponge pockets, one saline-filled syringe per sponge per day, a handheld mirror a device holder, spare saline solution, and the device with headgear. <a href="https://www-jove-com.remotexs.ntu.edu.sg/files/ftp_upload/53542/53542fig2large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 3" src="/files/ftp_upload/53542/53542fig3.jpg" /> 
Figure 3. Participant study timeline. This timeline demonstrates a way to cycle study kits and devices through each 10 day participant enrollment in the study. <a href="https://www-jove-com.remotexs.ntu.edu.sg/files/ftp_upload/53542/53542fig3large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 4" src="/files/ftp_upload/53542/53542fig4.jpg" /> 
Figure 4.&#160;Self-applied tDCS sessions across n=20 participants. This figure demonstrates the completed, self-applied sessions across n=20 participants enrolled in the study. The initial session is completed in-clinic while the remaining nine sessions are completed through remote supervision in the participant&#39;s home. <a href="https://www-jove-com.remotexs.ntu.edu.sg/files/ftp_upload/53542/53542fig4large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>

Watch this Scientific Journal Video about A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS at JoVE.com

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

The goal of this pilot study is to describe a protocol for the remotely-supervised delivery of transcranial direct current stimulation (tDCS) so that the procedure maintains standards of in-clinic practice, including safety, reproducibility, and tolerability. The feasibility of this protocol was tested in participants with multiple sclerosis (MS).

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation (tDCS) in Multiple Sclerosis (MS)

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low amplitude direct currents to alter cortical ...

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Nanyang Technological University

Research

JoVE Journal

Medicine

17.3K Views.  NYU Langone Medical Center. The goal of this pilot study is to describe a protocol for the remotely-supervised delivery of transcranial direct current stimulation (tDCS) so that the procedure maintains standards of in-clinic practice, including safety, reproducibility, and tolerability. The feasibility of this protocol was tested in participants with multiple sclerosis (MS). 

Video: A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

Simultaneous EEG Monitoring During Transcranial Direct Current Stimulation

Transcranial direct current stimulation (tDCS) is a technique that delivers weak electric currents through the scalp. This constant electric current induces shifts in neuronal membrane excitability, resulting in secondary changes in cortical activity. Although tDCS has most of its neuromodulatory effects on the underlying cortex, tDCS effects can also be observed in distant neural networks. Therefore, concomitant EEG monitoring of the effects of tDCS can provide valuable information on the mechanisms of tDCS. In addition, EEG findings can be an important surrogate marker for the effects of tDCS and thus can be used to optimize its parameters. This combined EEG-tDCS system can also be used for preventive treatment of neurological conditions characterized by abnormal peaks of cortical excitability, such as seizures. Such a system would be the basis of a non-invasive closed-loop device. In this article, we present a novel device that is capable of utilizing tDCS and EEG simultaneously. For that, we describe in a step-by-step fashion the main procedures of the application of this device using schematic figures, tables and video demonstrations. Additionally, we provide a literature review on clinical uses of tDCS and its cortical effects measured by EEG techniques.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown initial therapeutic effects in several neurological conditions. The main mechanism underlying these therapeutic effects is the modulation of cortical excitability. Therefore, online monitoring of cortical excitability would help guide stimulation parameters and optimize its therapeutic effects. In the present article we review the use of a novel device that combines simultaneous tDCS and EEG monitoring in real time.

Transcranial  direct current stimulation (tDCS) is a technique that delivers weak electric  currents through the scalp. This constant electric current ...

Behavior

Transcranial Direct Current Stimulation and Simultaneous  Functional Magnetic Resonance Imaging

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses weak electrical currents administered to the scalp to manipulate cortical excitability and, consequently, behavior and brain function. In the last decade, numerous studies have addressed short-term and long-term effects of tDCS on different measures of behavioral performance during motor and cognitive tasks, both in healthy individuals and in a number of different patient populations. So far, however, little is known about the neural underpinnings of tDCS-action in humans with regard to large-scale brain networks. This issue can be addressed by combining tDCS with functional brain imaging techniques like functional magnetic resonance imaging (fMRI) or electroencephalography (EEG).
In particular, fMRI is the most widely used brain imaging technique to investigate the neural mechanisms underlying cognition and motor functions. Application of tDCS during fMRI allows analysis of the neural mechanisms underlying behavioral tDCS effects with high spatial resolution across the entire brain. Recent studies using this technique identified stimulation induced changes in task-related functional brain activity at the stimulation site&#160;and also in more distant brain regions, which were associated with behavioral improvement. In addition, tDCS administered during resting-state fMRI allowed identification of widespread changes in whole brain functional connectivity.
Future studies using this combined protocol should yield new insights into the mechanisms of tDCS action in health and disease and new options for more targeted application of tDCS in research and clinical settings. The present manuscript describes this novel technique in a step-by-step fashion, with a focus on technical aspects of tDCS administered during fMRI.

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique. It has successfully been used in basic research and clinical settings to modulate brain function in humans. This article describes the implementation of tDCS and simultaneous functional magnetic resonance imaging (fMRI), to investigate the neural basis of tDCS effects.

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses weak electrical currents administered to the scalp ...

Effects of Transcranial Alternating Current Stimulation on the Primary Motor Cortex by Online Combined Approach with Transcranial Magnetic Stimulation

Transcranial Alternating Current Stimulation (tACS) is a neuromodulatory technique able to act through sinusoidal electrical waveforms in a specific frequency and in turn modulate ongoing cortical oscillatory activity. This neurotool allows the establishment of a causal link between endogenous oscillatory activity and behavior. Most of the tACS studies have shown online effects of tACS. However, little is known about the underlying action mechanisms of this technique because of the AC-induced artifacts on Electroencephalography (EEG) signals. Here we show a unique approach to investigate online physiological frequency-specific effects of tACS of the primary motor cortex (M1) by using single pulse Transcranial Magnetic Stimulation (TMS) to probe cortical excitability changes. In our setup, the TMS coil is placed over the tACS electrode while Motor Evoked Potentials (MEPs) are collected to test the effects of the ongoing M1-tACS. So far, this approach has mainly been used to study the visual and motor systems. However, the current tACS-TMS setup can pave the way for future investigations of cognitive functions. Therefore, we provide a step-by-step manual and video guidelines for the procedure.

Transcranial Alternating Current Stimulation (tACS) allows the modulation of cortical excitability in a frequency-specific fashion. Here we show a unique approach which combines online tACS with single pulse Transcranial Magnetic Stimulation (TMS) in order to "probe" cortical excitability by means of Motor Evoked Potentials.

Transcranial Alternating Current Stimulation (tACS) is a neuromodulatory technique able to act through sinusoidal electrical waveforms in a specific ...

Neuroscience

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

The remotely supervised tDCS (RS-tDCS) protocol enables participation from home through guided and monitored self-administration of tDCS treatment while maintaining clinical standards. The current consensus regarding the efficacy of tDCS is that multiple treatment sessions are needed to observe targeted behavioral reductions in symptom burden. However, the requirement for patients to travel to clinic daily for stimulation sessions presents a major obstacle for potential participants, due to work or family obligations or limited ability to travel. This study presents a protocol that directly overcomes these obstacles by eliminating the need to travel to clinic for daily sessions.
This is an updated protocol for remotely supervised self-administration of tDCS for daily treatment sessions paired with a program of computer-based cognitive training for use in clinical trials. Participants only need to attend clinic twice, for a baseline and study-end visit. At baseline, participants are trained and provided with a study stimulation device, and a small laptop computer. Participants then complete the remainder of their stimulation sessions at home while they are monitored via videoconferencing software.
Participants complete computerized cognitive remediation during stimulation sessions, which may serve a therapeutic role or as a &#34;placeholder&#34; for other computer-based activity. Computers are enabled for real-time monitoring and remote control by study staff.
Outcome measures that assess feasibility and tolerance are administered remotely with the aid of visual analogue scales that are presented onscreen. Following completion of all RS-tDCS sessions, participants return to clinic for a study end visit in which all study equipment is returned.
Results support the safety, feasibility, and scalability of the RS-tDCS protocol for use in clinical trials. Across 46 patients, 748 RS-tDCS sessions have been completed. This protocol serves as a model for use in future clinical trials involving tDCS.

This manuscript provides an updated remote supervision protocol that enables participation in transcranial direct current stimulation (tDCS) clinical trials while receiving treatment sessions from home. The protocol has been successfully piloted in both patients with multiple sclerosis and Parkinson&#39;s disease.

The remotely supervised tDCS (RS-tDCS) protocol enables participation from home through guided and monitored self-administration of tDCS treatment while ...

Combined Transcranial Magnetic Stimulation and Electroencephalography of the Dorsolateral Prefrontal Cortex

Transcranial magnetic stimulation (TMS) is a non-invasive method that produces neural excitation in the cortex by means of brief, time-varying magnetic field pulses. The initiation of cortical activation or its modulation depends on the background activation of the neurons of the cortical region activated, the characteristics of the coil, its position and its orientation with respect to the head. TMS combined with simultaneous electrocephalography (EEG) and neuronavigation (nTMS-EEG) allows for the assessment of cortico-cortical excitability and connectivity in almost all cortical areas in a reproducible manner. This advance makes nTMS-EEG a powerful tool that can accurately assess brain dynamics and neurophysiology in test-retest paradigms that are required for clinical trials. Limitations of this method include artifacts that cover the initial brain reactivity to stimulation. Thus, the process of removing artifacts may also extract valuable information. Moreover, the optimal parameters for dorsolateral prefrontal (DLPFC) stimulation are not fully known and current protocols utilize variations from the motor cortex (M1) stimulation paradigms. However, evolving nTMS-EEG designs hope to address these issues. The protocol presented here introduces some standard practices for assessing neurophysiological functioning from stimulation to the DLPFC that can be applied in patients with treatment resistant psychiatric disorders that receive treatment such as transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), magnetic seizure therapy (MST) or electroconvulsive therapy (ECT).

The protocol presented here is for TMS-EEG studies utilizing intracortical excitability test-retest design paradigms. The intent of the protocol is to produce reliable and reproducible cortical excitability measures for assessing neurophysiological functioning related to therapeutic interventions in the treatment of neuropsychiatric diseases such as major depression.

Transcranial magnetic stimulation (TMS) is a non-invasive method that produces neural excitation in the cortex by means of brief, time-varying magnetic ...

The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb

Neurologic disorders such as stroke and cerebral palsy are leading causes of long-term disability and can lead to severe incapacity and restriction of daily activities due to lower and upper limb impairments. Intensive physical and occupational therapy are still considered main treatments, but new adjunct therapies to standard rehabilitation that may optimize functional outcomes are being studied.
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that polarizes underlying brain regions through the application of weak direct currents through electrodes on the scalp, modulating cortical excitability. Increased interest in this technique can be attributed to its low cost, ease of use, and effects on human neural plasticity. Recent research has been performed to determine the clinical potential of tDCS in diverse conditions such as depression, Parkinson&#39;s disease, and motor rehabilitation after stroke. tDCS helps enhance brain plasticity and seems to be a promising technique in rehabilitation programs.
A number of robotic devices have been developed to assist in the rehabilitation of upper limb function after stroke. The rehabilitation of motor deficits is often a long process requiring multidisciplinary approaches for a patient to achieve maximum independence. These devices do not intend to replace manual rehabilitation therapy; instead, they were designed as an additional tool to rehabilitation programs, allowing immediate perception of results and tracking of improvements, thus helping patients to stay motivated.
Both tDSC and robot-assisted therapy are promising add-ons to stroke rehabilitation and target the modulation of brain plasticity, with several reports describing their use to be associated with conventional therapy and the improvement of therapeutic outcomes. However, more recently, some small clinical trials have been developed that describe the associated use of tDCS and robot-assisted therapy in stroke rehabilitation. In this article, we describe the combined methods used in our institute for improving motor performance after stroke.

The combined use of transcranial direct current stimulation and robotic therapy as an add-on for conventional rehabilitation therapy may result in improved therapeutic outcomes due to modulation of brain plasticity. In this article, we describe the combined methods used in our institute for improving motor performance after stroke.

Neurologic disorders such as stroke and cerebral palsy are leading causes of long-term disability and can lead to severe incapacity and restriction of ...

Home-Based Transcranial Direct Current Stimulation Device Development: An Updated Protocol Used at Home in Healthy Subjects and Fibromyalgia Patients

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) method, which modulates the membrane potential of neurons in the cerebral cortex by a low-intensity direct current. tDCS is a low-cost technique with minimal adverse effects and easy application. This neurostimulation method has a promising future to improve pain therapy, treatment of neuropsychiatric disorders, and physical rehabilitation.
Current studies demonstrate the benefits of using tDCS over consecutive multiple sessions. However, the daily displacement to the specialized centers, travel costs, and disruptions to daily activities are some of the difficulties faced by patients. Thus, to be more comfortable, easy-to-use, and not disrupt daily commitments, a home-based tDCS was designed. Therefore, the objective of this study was to evaluate the feasibility of a portable tDCS device for home use in healthy subjects and fibromyalgia patients.
Despite increased tDCS use and a reasonably large body of research on the effects across a range of clinical conditions, there is a limited amount of research on developing secure devices that guarantee the dose and contain a block system to avoid excessive use. Therefore, we used a tDCS device with a security system to permit daily use for 20 minutes with a minimal interval of 12 hours between sessions. A programmer preconfigures the equipment, which has a neoprene cap that allows the electrode positions in any assembly, according to individualized protocols for treatments or research. After, researchers can assess the effectiveness of treatment, and its adherence using information kept in the device software.
Results suggest that the device is feasible for home use, with proper monitoring of adherence and contact impedance. There were reports of a few adverse effects, which do not differ from those reported in the literature in studies with the treatment under direct supervision.

This study provides an updated home-based tDCS protocol that enables subjects to receive the beneficial effects of tDCS at home with an easy to use device with settings to control the use and dosage, enhancing the feasibility for long-term use at home.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) method, which modulates the membrane potential of neurons in the ...

Measuring and Manipulating Functionally Specific Neural Pathways in the Human Motor System with Transcranial Magnetic Stimulation

Understanding interactions between brain areas is important for the study of goal-directed behavior. Functional neuroimaging of brain connectivity has provided important insights into fundamental processes of the brain like cognition, learning, and motor control. However, this approach cannot provide causal evidence for the involvement of brain areas of interest. Transcranial magnetic stimulation (TMS) is a powerful, noninvasive tool for studying the human brain that can overcome this limitation by transiently modifying brain activity. Here, we highlight recent advances using a paired-pulse, dual-site TMS method with two coils that causally probes cortico-cortical interactions in the human motor system during different task contexts. Additionally, we describe a dual-site TMS protocol based on cortical paired associative stimulation (cPAS) that transiently enhances synaptic efficiency in two interconnected brain areas by applying repeated pairs of cortical stimuli with two coils. These methods can provide a better understanding of the mechanisms underlying cognitive-motor function as well as a new perspective on manipulating specific neural pathways in a targeted fashion to modulate brain circuits and improve behavior. This approach may prove to be an effective tool to develop more sophisticated models of brain-behavior relations and improve diagnosis and treatment of many neurological and psychiatric disorders.

This article describes new approaches to measure and strengthen functionally specific neural pathways with transcranial magnetic stimulation. These advanced noninvasive brain stimulation methodologies can provide new opportunities for the understanding of brain-behavior relations and development of new therapies to treat brain disorders.

Understanding interactions between brain areas is important for the study of goal-directed behavior. Functional neuroimaging of brain connectivity has ...

Updated Technique for Reliable, Easy, and Tolerated Transcranial Electrical Stimulation Including Transcranial Direct Current Stimulation

Transcranial direct current stimulation (tDCS) is a noninvasive method of neuromodulation using low-intensity direct electrical currents. This method of brain stimulation presents several potential advantages compared to other techniques, as it is noninvasive, cost-effective, broadly deployable, and well-tolerated provided proper equipment and protocols are administered. Even though tDCS is apparently simple to perform, correct administration of the tDCS session, especially the electrode positioning and preparation, is vital for ensuring reproducibility and tolerability. The electrode positioning and preparation steps are traditionally also the most time consuming and error-prone. To address these challenges, modern tDCS techniques, using fixed-position headgear and pre-assembled sponge electrodes, reduce complexity and setup time while also ensuring that the electrodes are consistently placed as intended. These modern tDCS methods present advantages for research, clinic, and remote-supervised (at home) settings. This article provides a comprehensive step-by-step guide for administering a tDCS session using fixed-position headgear and pre-assembled sponge electrodes. This guide demonstrates tDCS using commonly applied montages intended for motor cortex and dorsolateral prefrontal cortex (DLPFC) stimulation. As described, selection of the head size and montage-specific headgear automates electrode positioning. Fully assembled pre-saturated snap-electrodes are simply affixed to the set position snap-connectors on the headgear. The modern tDCS method is shown to reduce setup time and reduce errors for both novice and expert operators. The methods outlined in this article can be adapted to different applications of tDCS as well as other forms of transcranial electrical stimulation (tES) such as transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS). However, since tES is application specific, as appropriate, any methods recipe is customized to accommodate subject, indication, environment, and outcome specific features.

When administering transcranial direct current stimulation (tDCS), reproducible electrode preparation and placement are vital for a tolerated and effective session. The purpose of this article is to demonstrate updated modern setup procedures for the administration of tDCS and related transcranial electrical stimulation techniques, such as transcranial alternating current stimulation (tACS).

Transcranial direct current stimulation (tDCS) is a noninvasive method of neuromodulation using low-intensity direct electrical currents. This method of ...

Treatment of Phantom Limb Pain by Remote Transcranial Direct Current Stimulation

Using Home-based, Remotely Supervised, Transcranial Direct Current Stimulation for Phantom Limb Pain

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical excitability. Previous trials have established the safety and tolerability of tDCS, and its potential to mitigate symptoms. However, the effects are cumulative, making it more difficult to have adherence to the treatment since frequent visits to the clinic or outpatient center are required. Moreover, the time needed for transportation to the center and the related expenses limit the accessibility of the treatment for many participants.
Following guidelines for remotely supervised transcranial direct current stimulation (RS-tDCS) implementation, we propose a protocol designed for remotely supervised and home-based participation that uses specific devices and materials modified for patient use, with real-time monitoring by researchers through an encrypted video conferencing platform. We have developed detailed instructional materials and structured training procedures to allow for self- or proxy-administration while supervised remotely in real time. This protocol has a specific design to have a series of checkpoints during training and execution of the visit. This protocol is currently in use in a large pragmatic study of RS-tDCS for phantom limb pain (PLP). In this article, we will discuss the operational challenges of conducting a home-based RS-tDCS session and show methods to enhance its efficacy with supervised sessions.

Author Spotlight: Insights into Remotely Supervised Neuromodulation Procedure for Phantom Limb Pain

The goal of this study is to describe a protocol for the home-based delivery of remotely supervised transcranial direct current stimulation (RS-tDCS) conserving the standard procedures of in-clinic practice, including safety, reproducibility, and tolerability. The participants included will be patients with phantom limb pain (PLP).

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical ...

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation (tDCS) in Multiple Sclerosis (MS)

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