A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimu
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
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
- Active RS-tDCS +At-Home Manual Dexterity Training
Placebo
- Sham RS-tDCS +At-Home Manual Dexterity Training
Given to everyone in the trial
- Manual dexterity training
Results by group
Mean Preload Phase Duration (PLD)
baseline and 30 minutes for each of 20 sessions, values averaged across sessions
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RS-tDCS Stimulation | 0.152 seconds | 0.0424 (Standard Deviation) | 30 |
| Sham Stimulation | 0.238 seconds | 0.0481 (Standard Deviation) | 24 |
| RS-tDCS Stimulation | 0.163 seconds | 0.0426 (Standard Deviation) | 30 |
| Sham Stimulation | 0.202 seconds | 0.0476 (Standard Deviation) | 24 |
RS-tDCS Stimulation
Sham Stimulation
RS-tDCS Stimulation
Sham Stimulation
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| RS-tDCS Stimulation | 33 | 0 (0.0%) | 0 |
| Sham Stimulation | 32 | 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
Mean Preload Phase Duration (PLD)
baseline and 30 minutes for each of 20 sessions, values averaged across sessions
Who could take part
Progressive MS · 18 to 70
Show the full criteria
Inclusion criteria
* Definite MS diagnosis, progressive subtype * 9HPT score between -1.0 and -4.0 standard deviations from age-based normative data * Score of \< 7.5 or less on the EDSS (with caregiver proxy required for those with scores of 6.5 or greater)* * Ability to understand the informed consent process and provide consent to participate in the study
Exclusion criteria
* Primary neurologic, psychiatric or other medical disorder other than MS * Use of upper extremity Botox injection within 3 months * Current use of intrathecal Baclofen * History of seizure disorder * History of head trauma or medical device in head or neck * Clinically significant abnormality on EKG * Symbol Digit Modalities Test or SDMT score ≥3.0 SD from published norms * WRAT-4 reading level below average (\<85) (estimated general intellectual function) * Skin disorder/sensitive near stimulation locations
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to rehabilitate fine motor function in individuals living with progressive multiple sclerosis (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity training. Treatment will be delivered to individuals at home using a state-of-the-art remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study visit participation. Improvements in fine motor skill will be assessed at each remote session using a novel portable grip device that measures execution and adaptation or learning of fingertip forces during grasp, which is more sensitive than standard measures of hand function.
Papers
Loading reviews and guidelines…
History
Started
Apr 2018
Main results due
Nov 2020
Finished
Nov 2020
Results posted
Mar 2022