N/A
N=31
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02746705 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: The Number of Participants Completing at Least 80% of the Targeted Sessions. — 15; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (tDCS) (Device); Sham Transcranial Direct Current Stimulation (Device); Cognitive Training Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Completing at Least 80% of the Targeted Sessions. |
15; 12 | — |
| PRIMARY Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS) |
0.12; 0.29 | — |
| SECONDARY Change in Score on Modified Fatigue Impact Scale (MFIS) |
-11.3; -0.44 | — |
| SECONDARY Change in Score of CogState Brief Battery (CBB) |
-0.02; -0.04 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02746705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.