All procedures were conducted under institutionally approved protocols with patient consent. See Figure 1 for an image of the intervention kit and main components and Figure 2 for the RS-tDCS session structure.
1. Pre-intervention procedures
<ol>
	<li>Perform recruitment pre-screening according to inclusion and exclusion criteria. Include patients who are adult amputees, who regularly experience phantom pain once a ...

Treatment of Phantom Limb Pain by Remote Transcranial Direct Current Stimulation

<ol>
	<li>Gunduz, M. 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=Effects+of+combined+and+alone+transcranial+motor+cortex+stimulation+and+mirror+therapy+in+phantom+limb+pain:+A+randomized+factorial+trial.">Effects of combined and alone transcranial motor cortex stimulation and mirror therapy in phantom limb pain: A randomized factorial trial.</a> Neurorehabilitation and Neural Repair. 35 (8), 704-716 (2021).</li><li>Pacheco-Barrios, K., Meng, X., Fregni, F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Neuromodulation+techniques+in+phantom+limb+pain:+A+systematic+review+and+meta-analysis.">Neuromodulation techniques in phantom limb pain: A systematic review and meta-analysis.</a> Pain Medicine. 21 (10), 2310-2322 (2020).</li><li>Segal, N., 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=Additive+analgesic+effect+of+transcranial+direct+current+stimulation+together+with+mirror+therapy+for+the+treatment+of+phantom+pain.">Additive analgesic effect of transcranial direct current stimulation together with mirror therapy for the treatment of phantom pain.</a> Pain Medicine. 22 (2), 255-265 (2021).</li><li>Fregni, F., 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=Evidence-based+guidelines+and+secondary+meta-analysis+for+the+use+of+transcranial+direct+current+stimulation+in+neurological+and+psychiatric+disorders.">Evidence-based guidelines and secondary meta-analysis for the use of transcranial direct current stimulation in neurological and psychiatric disorders.</a> International Journal of Neuropsychopharmacology. 24 (4), 256-313 (2021).</li><li>Silva-Filho, 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=Factors+supporting+availability+of+home-based+neuromodulation+using+remote+supervision+in+middle-income+countries;+Brazil+experience.">Factors supporting availability of home-based neuromodulation using remote supervision in middle-income countries; Brazil experience.</a> Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation. 15 (2), 385-387 (2022).</li><li>Pacheco-Barrios, K., 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=Methods+and+strategies+of+tDCS+for+the+treatment+of+pain:+current+status+and+future+directions.">Methods and strategies of tDCS for the treatment of pain: current status and future directions.</a> Expert Review of Medical Devices. 17 (9), 879-898 (2020).</li><li>Brunoni, A. R., 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=Digitalized+transcranial+electrical+stimulation:+A+consensus+statement.">Digitalized transcranial electrical stimulation: A consensus statement.</a> Clinical Neurophysiology. 143, 154-165 (2022).</li><li>Sandran, N., Hillier, S., Hordacre, B. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Strategies+to+implement+and+monitor+in-home+transcranial+electrical+stimulation+in+neurological+and+psychiatric+patient+populations:+a+systematic+review.">Strategies to implement and monitor in-home transcranial electrical stimulation in neurological and psychiatric patient populations: a systematic review.</a> Journal of Neuroengineering and Rehabilitation. 16 (1), 58 (2019).</li><li>Palm, U., 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=Home+use,+remotely+supervised,+and+remotely+controlled+transcranial+direct+current+stimulation:+A+systematic+review+of+the+available+evidence.">Home use, remotely supervised, and remotely controlled transcranial direct current stimulation: A systematic review of the available evidence.</a> Neuromodulation. 21 (4), 323-333 (2018).</li><li>Van Den Houte, M., Van Oudenhove, L., Bogaerts, K., Van Diest, I., Vanden Bergh, O. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Endogenous+pain+modulation:+association+with+resting+heart+rate+variability+and+negative+affectivity.">Endogenous pain modulation: association with resting heart rate variability and negative affectivity.</a> Pain Medicine. 19 (8), 1587-1596 (2018).</li><li>Cousins, M. J., Lynch, M. E. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Declaration+Montreal:+access+to+pain+management+is+a+fundamental+human+right.">The Declaration Montreal: access to pain management is a fundamental human right.</a> Pain. 152, 2673-2674 (2011).</li><li>Maceira-Elvira, P., Popa, T., Schmid, A. -. C., Hummel, F. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Feasibility+of+home-based,+self-applied+transcranial+direct+current+stimulation+to+enhance+motor+learning+in+middle-aged+and+older+adults.">Feasibility of home-based, self-applied transcranial direct current stimulation to enhance motor learning in middle-aged and older adults.</a> Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation. 13 (1), 247-249 (2020).</li><li>Tsapkini, K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Home-based+transcranial+direct+current+stimulation:+Are+we+there+yet.">Home-based transcranial direct current stimulation: Are we there yet.</a> Stroke. 53 (10), 3002-3003 (2022).</li></ol>

Aspects of training, challenges, and solutions 
Given the nature of this research study and the type of intervention, being home-based, some challenges have risen; among them were day-to-day issues such as internet connection, contact quality of the operated device, and getting familiar with the devices. The potential challenges presented by RS-tDCS research have been overcome through several creative solutions. Prior to every session, the internet connection is checked on both ends to minimize inte...

The sensation of pain and discomfort experienced in an amputated limb and referred to as phantom limb pain (PLP) is a complex condition, challenging to treat, consisting of a refractory nature that contributes to the difficulty in achieving complete and long-lasting pain relief and management. The lack of effective treatment owing to its neuropathic nature, resulting from abnormal nerve activity, or signaling, neural plasticity, psychological factors, and limited understanding and research, influences the complexity of the phenomenon in the pain presentation and the treatment outcomes. From all available treatments, recent studies using transcranial direct current stimulation (tDCS) have reported positive results when combining stimulation of the primary motor cortex (M1) with motor representation techniques1,2,3,4. As Kikkert et al. published in 2019, the long-term effects of the combined stimulation resulted in significant, maintained pain reduction after intervention and a follow-up period of 3 months, with meaningful improvements and large effect sizes in lower-limb amputees.
Although the effects are promising, the clinical translations of these results are limited due to geographical constraints and disabilities related to amputations, which delay and affect the access to adequate post-amputation rehabilitation5. One solution is to deploy these interventions in remote environments using digital technologies and telehealth approaches6. A recent international consensus reported the requirements to successfully implement digitalized electrical stimulation7, including a support team available at all times to manage medical emergencies, cost optimization strategies, implementation of insurance coverage for further field development, specialized teams or third-party services for undertaking the development of software and hardware for the remote use of devices, digital marketing strategies to enhance publicity among potential patients, and front-end interfaces for user experience enhancement.
The adequate implementation of remotely supervised transcranial direct current stimulation (RS-tDCS) protocols has the potential to accelerate the clinical application of this safe and effective intervention4 and facilitate its combination with behavioral modalities that can be performed at home (e.g., physical therapy, mindfulness). Recent studies have shown feasibility and equivalent results with RS-tDCS compared to previous on-site tDCS studies for the same condition8,9. However, practical details and guidance on how to implement RS-tDCS for clinical trials in chronic pain are still limited in the literature. There are open questions on RS-tDCS such as the need for online supervision performed by a trained specialist in the technique compared to the self-administered tDCS therapy after receiving proper coaching. Furthermore, questions remain unanswered regarding metadata registration, adherence to the treatment guidelines, the use of technology such as apps to track contact quality and time of usage, avoiding the misuse of devices related to non-scheduled stimulation sessions, and topics associated with &#34;internet issues&#34;-protection of personal information, recording of health records, rules of sharing, and password protection for access.
Therefore, our goal is to provide a visual guideline on how to perform an RS-tDCS session, as well as a description of the logistics and challenges of its implementation for treating phantom limb pain (PLP) in the context of a pragmatic clinical trial.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>1 x 1 tDCS mini-CT stimulator</td>
			<td>Soterix&#160;</td>
			<td></td>
			<td>parameters preset to two milliamps of stimulation for 20 min</td>
		</tr>
		<tr>
			<td>Lenovo Laptop&#160;</td>
			<td>Lenovo</td>
			<td></td>
			<td>It contains a headstrap and disposable clip-on sponges for stimulation. A computer with Zoom access, to conduct the RS-tDCS sessions. The Zoom videocalls will be addressed to a secured account by Mass General Brigham (MGB)&#160;&#160;</td>
		</tr>
		<tr>
			<td>Lenovo Smart Tab M8 8&#39;&#39;</td>
			<td>Lenovo</td>
			<td></td>
			<td>We also record the heart rate variability (HRV) and therefore, we provide a tablet with the Polar app installed and the chest HR monitor.</td>
		</tr>
		<tr>
			<td>Polar H10 Heart Rate Monitor</td>
			<td></td>
			<td></td>
			<td>POLAR device, in addition to the materials for the RS-tDCS intervention, we also record the heart rate variability (HRV) and therefore we provide a tablet with the Polar app installed and the chest HR monitor.</td>
		</tr>
		<tr>
			<td>Saline solution with a syringe for application over the sponges</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>SNAP Headgear accessories</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>&#160; SNAPstrap, motor left (anode: C3, cathode: supraorbital) or motor right (anode: c4, cathode: supraorbital) according to the side of amputation (contralateral to stimulation)</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>&#160;&#160; SNAPpads, 5 x 7 CMS with pre-inserted carbon rubber snap electrode sites located on the SNAPstrap</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Webcam</td>
			<td></td>
			<td></td>
			<td>to ensure a proper visualization of the electrode placement</td>
		</tr>
	</tbody>
</table>

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

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

From all available treatments, recent studies using transcranial direct current stimulation, tDCS, have reported positive results when combining stimulation of the primary motor cortex, M1, with motor representation techniques. The long-term effects of the combined stimulation resulted in significant, maintained pain reduction after intervention and a follow-up period of three months. Our goal is to provide a visual guideline on how to perform a remote supervised tDCS session, as well as a description of the logistics and challenges of its implementation for treating phantom limb pain, especially in the context of a pragmatic clinical trial.Another important contribution of this protocol is that most of the insights we are providing here can be translated to other studied population such as Parkinson's disease, traumatic brain injury, and post-stroke rehabilitation. Practical details and guidance on how to implement RS-tDCS for clinical trials on chronic pain are still limited in the literature, and they have the potential to accelerate the clinical application of the safe and effective intervention. And so on, facilitate its combination with the behavioral modalities that can be performed at home.This trial will provide significant insights in how to use remotely supervised neuromodulation. After this trial, we'll focus on improving the delivery and methodology of home-based devices to increase the reach and the use of neuromodulation techniques in rehabilitation. We think that by addressing these questions, the clinical use of neuromodulation will increase.

Our home-based and remotely supervised protocol is currently being tested in a large, pragmatic, randomized, clinical trial of patients with PLP. Based on previous clinical trial testing in-clinic tDCS in PLP patients, we expect a reduction in the level of PLP, PLS, and RLP compared to the usual care group. This reduction is expected to reach an effect size of at least 0.5, namely a clinically important difference.
Regarding safety outcomes, our initial exploration has shown a similar safety p...

Watch this Scientific Journal Video about Using Home-based, Remotely Supervised, Transcranial Direct Current Stimulation for Phantom Limb Pain at JoVE.com

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 ...

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Research

JoVE Journal

Neuroscience

Remotely Supervised Protocol for Transcranial Direct Current Stimulation to Treat Phantom Limb Pain

554 Views.  Massachusetts General Hospital, Harvard Medical School.  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).

Treatment of Phantom Limb Pain by Remote Transcranial Direct Current Stimulation

概要