Transcranial Direct Current Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis

doi:10.1111/ner.12430

Neuromodulation: Technology at the Neural Interface

Volume 19, Issue 8, December 2016, Pages 824-831

https://doi.org/10.1111/ner.12430 Get rights and content

Objectives

Transcranial direct current stimulation (tDCS) has potential clinical application for symptomatic management in multiple sclerosis (MS). Repeated sessions are necessary in order to adequately evaluate a therapeutic effect. However, it is not feasible for many individuals with MS to visit clinic for treatment on a daily basis, and clinic delivery is also associated with substantial cost. We developed a research protocol to remotely supervise self- or proxy-administration for home delivery of tDCS using specially designed equipment and a telemedicine platform.

Materials and Methods

We targeted ten treatment sessions across two weeks. Twenty participants (n = 20) diagnosed with MS (any subtype), ages 30 to 69 years with a range of disability (Expanded Disability Status Scale or EDSS scores of 1.0 to 8.0) were enrolled to test the feasibility of the remotely supervised protocol.

Results

Protocol adherence exceeded what has been observed in studies with clinic-based treatment delivery, with all but one participant (95%) completing at least eight of the ten sessions. Across a total of 192 supervised treatment sessions, no session required discontinuation and no adverse events were reported. The most common side effects were itching/tingling at the electrode site.

Conclusions

This remotely supervised tDCS protocol provides a method for safe and reliable delivery of tDCS for clinical studies in MS and expands patient access to tDCS.

Section snippets

INTRODUCTION

Multiple sclerosis (MS) is the most common neurological disorder among adults of working age (1), and is associated with tremendous cost in terms of both economic viability and quality of life. MS is characterized by demyelination, immune-mediated inflammation, and neurodegeneration within the central nervous system (2,3). The most common subtype is relapsing-remitting and over half of these individuals transition to a progressive course; the remainder have a progressive course from the onset (4

Ethics Statement

Stony Brook University Institutional Review Board (IRB) approved this protocol on February 10, 2015 (2014-2877-F).

Participants

All participants were recruited through the Stony Brook Medicine MS Comprehensive Care Center. Prior to the baseline visit, all enrolled participants were given medical clearance by a study physician to ensure that no conditions contraindicated for tDCS treatment were observed. The full list of inclusion/exclusion criteria specific to the requirements of a remotely administered tDCS

RESULTS

The study was met with strong demand by potential participants and rate of enrollment was controlled by device availability. Over the course of approximately six months, n = 20 MS participants were enrolled, with a waitlist of more than 30 interested candidates. Table 3 shows the participant characteristics.

DISCUSSION

In this pilot study, we found that remotely supervised home delivery is feasible and well-tolerated for study in a diverse sample of MS participants using our structured protocol. The extensive procedures for remote supervision, including real-time monitoring through videoconferencing, ensure for safety and tolerability while also providing reliable and reproducible stimulation sessions.

Offering trial participation and treatment to those living with MS who otherwise would not be able to travel

CONCLUSION

In sum, our remotely supervised protocol provides an option for delivering tDCS to those living with MS. With controlled study to determine parameters for optimal use, it has the potential to transform the standard of care for a range of symptoms in MS. If established as a clinical treatment, tDCS could be delivered through the telemedicine platform developed here.

Authorship Statement

Dr. Charvet, Ms. Kasschau and Ms. Sherman designed the study with intellectual input from Drs. Bikson and Abishek. Ms. Kasschau, Ms. Sherman and Mr. Reisner conducted the study including patient recruitment and data collection. Dr. Charvet and Ms. Kasschau completed the data analyses and drafted the manuscript. All authors approved the final manuscript.

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Despite their promising findings, it must be recognized that the preceding studies assessing the effects of repetitive stimulation on walking and postural stability are few in number and lack complete methodology regarding stimulation procedures. Although tDCS appears feasible for remote home usage in PwMS, studies are still being conducted assessing the efficacy of its use for ameliorating lower limb motor impairment (Kasschau, Reisner et al. 2016). To-date, only a few small studies have been conducted assessing the effects of tDCS on lower limb impairments in PwMS, in which improving gait and spasticity are the primary focus.
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For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/WileyCDA/Section/id-301854.html

Source(s) of financial support: This project was funded with support from The Lourie Foundation, Inc.

View full text

Noninvasive Brain StimulationTranscranial Direct Current Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis

Objectives

Materials and Methods

Results

Conclusions

Section snippets

INTRODUCTION

Ethics Statement

Participants

RESULTS

DISCUSSION

CONCLUSION

Authorship Statement

Trends Neurosci

Brain Stimul

Brain Stimul

Brain Stimul

Pain

J Pain

Brain Stimul

Trends Neurosci

Brain Stimul

Neurosci Lett

Clin Neurophysiol

Exp Neurol

Prog Neuropsychopharmacol Biol Psychiatr

Brain Stimul

Pain

J Pain

Brain Res Bull

Neuromodulation

The accuracy of prevalence rates of multiple sclerosis: a critical review

Neuroepidemiology

Multiple sclerosis–the plaque and its pathogenesis

N Engl J Med

Natural history of multiple sclerosis: a unifying concept

Brain

Transcranial direct current stimulation in the treatment of major depression: a meta-analysis

Psychol Med

Bilateral dorsolateral prefrontal cortex modulation for tinnitus by transcranial direct current stimulation: a preliminary clinical study

Exp Brain Res

Repetitive transcranial magnetic stimulation or transcranial direct current stimulation?

Brain Stimul

Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial

Br J Psychiatr

Transcranial direct current stimulation (tDCS) for sleep disturbances and fatigue in patients with post-polio syndrome

Restor Neurol Neurosci

Impact of transcranial direct current stimulation on fatigue in multiple sclerosis

Restor Neurol Neurosci

Safety and cognitive effect of frontal DC brain polarization in healthy individuals

Neurology

Noninvasive Brain Stimulation
Transcranial Direct Current Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis