Multiple Sclerosis
Conditions
Keywords
Anodal transcranial stimulation (tDCS)
Brief summary
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.
Interventions
DEVICEActive RS-tDCS +At-Home Manual Dexterity Training
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
DEVICESham RS-tDCS +At-Home Manual Dexterity Training
Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds
OTHERManual dexterity training
Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Preload Phase Duration (PLD) | baseline and 30 minutes for each of 20 sessions, values averaged across sessions | (PLD) is the duration of finger contact until the onset of positive load force. It assesses the time taken to stabilize grasp and is a robust measure of grasp execution. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RS-tDCS Stimulation 20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training. | 33 |
| Sham Stimulation 20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training. | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Medical issue unrelated to research study | 1 | 1 |
| Overall Study | Time Commitment | 1 | 2 |
Baseline characteristics
| Characteristic | RS-tDCS Stimulation | Total | Sham Stimulation |
|---|---|---|---|
| Age, Continuous | 55.23 years STANDARD_DEVIATION 8.58 | 54.49 years STANDARD_DEVIATION 8.11 | 53.72 years STANDARD_DEVIATION 7.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 65 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 56 Participants | 28 Participants |
| Region of Enrollment United States | 33 participants | 65 participants | 32 participants |
| Sex: Female, Male Female | 22 Participants | 46 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 24 / 33 | 22 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
Mean Preload Phase Duration (PLD)
(PLD) is the duration of finger contact until the onset of positive load force. It assesses the time taken to stabilize grasp and is a robust measure of grasp execution.
Time frame: baseline and 30 minutes for each of 20 sessions, values averaged across sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RS-tDCS Stimulation | Mean Preload Phase Duration (PLD) | Pre-Stimulation | 0.152 seconds | Standard Deviation 0.0424 |
| RS-tDCS Stimulation | Mean Preload Phase Duration (PLD) | Post-Stimulation | 0.163 seconds | Standard Deviation 0.0426 |
| Sham Stimulation | Mean Preload Phase Duration (PLD) | Pre-Stimulation | 0.238 seconds | Standard Deviation 0.0481 |
| Sham Stimulation | Mean Preload Phase Duration (PLD) | Post-Stimulation | 0.202 seconds | Standard Deviation 0.0476 |