Pilot Study of Transcranial Direct Current Stimulation (tDCS)
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Apr 2016
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedResults Posted
Study results publicly available
May 8, 2020
CompletedMay 8, 2020
April 1, 2020
2.5 years
April 4, 2016
September 18, 2019
April 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
The Number of Participants Completing at Least 80% of the Targeted Sessions.
80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Four Weeks
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
BICAMS comprises two tests, the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test-Revised (BVMT-R). Scoring for SDMT involves summing the number of correct substitutions within the 90 second interval (max = 110. The higher the score, the better). Visual/spatial memory is assessed in BICAMS using the BVMTR. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12 (the higher the score, the better). The total score range for BICAMS is 0-122. The higher the score, the better.
Baseline, Four Weeks
Secondary Outcomes (2)
Change in Score on Modified Fatigue Impact Scale (MFIS)
Baseline, 4 Weeks
Change in Score of CogState Brief Battery (CBB)
Baseline, 4 Week
Study Arms (2)
Transcranial Direct Current Stimulation (tDCS)
ACTIVE COMPARATORSham Transcranial Direct Current Stimulation (tDCS)
SHAM COMPARATORInterventions
tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Stony Brook Universitycollaborator
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10016, United States
Related Publications (1)
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.
PMID: 30522497DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Leigh Charvet
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Leigh Charvet
NYU Langone Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 21, 2016
Study Start
April 1, 2016
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
May 8, 2020
Results First Posted
May 8, 2020
Record last verified: 2020-04