Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Transcranial Direct Current Stimulation (tDCS)
- Cognitive Training Program
Placebo
- Sham Transcranial Direct Current Stimulation
Results by group
The Number of Participants Completing at Least 80% of the Targeted Sessions.
Four Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | 15 participants | 15 | |
| Sham Transcranial Direct Current Stimulation (tDCS) | 12 participants | 12 |
Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
Baseline, Four Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | 0.12 score on a scale | 0.47 (Standard Deviation) | 15 |
| Sham Transcranial Direct Current Stimulation (tDCS) | 0.29 score on a scale | 0.63 (Standard Deviation) | 11 |
Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | 17 | 0 (0.0%) | 0 |
| Sham Transcranial Direct Current Stimulation (tDCS) | 14 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
The Number of Participants Completing at Least 80% of the Targeted Sessions.
Four Weeks
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
Baseline, Four Weeks
Thinking and memory
Other measures (2)
Change in Score on Modified Fatigue Impact Scale (MFIS)
Baseline, 4 Weeks
FatigueChange in Score of CogState Brief Battery (CBB)
Baseline, 4 Week
Thinking and memoryWalking and mobility
Who could take part
MS (type not specified) · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease.J Neuroeng Rehabil · 2018
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History
Started
Apr 2016
Main results due
Sept 2018
Finished
Sept 2018
Results posted
May 2020