Clinical trial NCT02746705: Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Stony Brook University
First posted: 2016-04-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the tolerability and preliminary efficacy of transcranial direct current stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive impairment and fatigue.

Detailed description: Transcranial direct current stimulation (tDCS) has been demonstrated to:

1. successfully treat fatigue in adults with MS, and
2. improve learning ability and other aspects of cognitive functioning in healthy controls and in participants with a range of medical disorders.

Cognitive impairment in MS remains a major treatment challenge and a trial of tDCS combined with a cognitive training program to treat MS-related cognitive impairment is warranted. However, one barrier for the study of tDCS has been the need for the participant to travel to the study site for each tDCS administration. To address this issue, the biomedical company Soterix, has recently designed a remote-delivery tDCS device designed for use in clinical trials. Therefore, the primary goal of this study is to establish a protocol for remotely-supervised in-home tDCS delivery for studies with MS participants. Established safety and feasibility of remotely-supervised tDCS delivery will facilitate the next steps of larger controlled trials, in both MS as well as other conditions, to determine efficacy and appropriate real-world use.

Eligibility criteria: Inclusion Criteria:

* Ages 18-70
* Definite MS diagnosis, all subtypes \[95\]
* MS-related changes in cognitive functioning
* A score of 6.5 or lesson the Expanded
* Disability Status Scale (EDSS) OR more than 6.5 with proxy
* Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable)
* Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/)
* Adequate home facilities (enough space, access to quiet and distraction free area)
* Able to commit to the two-week period of training sessions with baseline and follow-up visits.
* Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating neurologist or study staff
* Relapse or steroid use in previous month
* History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
* Primary psychiatric disorder that would influence ability to participate
* History of seizures or seizure disorder
* Current chronic headaches or migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded.
* History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
* Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
* Treatment for a communicable skin disorder currently or over the past 12 months

Primary outcomes:
measure: The Number of Participants Completing at Least 80% of the Targeted Sessions.
timeFrame: Four Weeks
measure: Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
timeFrame: Baseline, Four Weeks
Secondary outcomes:
measure: Change in Score on Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline, 4 Weeks
measure: Change in Score of CogState Brief Battery (CBB)
timeFrame: Baseline, 4 Week
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Leigh Charvet
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobbs B, Pawlak N, Biagioni M, Agarwal S, Shaw M, Pilloni G, Bikson M, Datta A, Charvet L. Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease. J Neuroeng Rehabil. 2018 Dec 7;15(1):114. doi: 10.1186/s12984-018-0457-9.