Multiple SclerosisNCT03499314
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
A study testing Active RS-tDCS +At-Home Manual Dexterity Training and Manual dexterity training in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Active RS-tDCS +At-Home Manual Dexterity Training and Manual dexterity training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Active RS-tDCS +At-Home Manual Dexterity Training, Sham RS-tDCS +At-Home Manual Dexterity Training, Manual dexterity training
- Keywords
- Anodal transcranial stimulation (tDCS)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RS-tDCS +At-Home Manual Dexterity TrainingDevice
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Sham RS-tDCS +At-Home Manual Dexterity TrainingDevice
Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RS-tDCS Stimulation | Experimental | 20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee Receives: Device: Active RS-tDCS +At-Home Manual Dexterity Training; Other: Manual dexterity training |
| Sham Stimulation | Placebo comparator | 20 ×20-minute sessions sham tDCS Receives: Device: Sham RS-tDCS +At-Home Manual Dexterity Training; Other: Manual dexterity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 30 minutes for each of 20 sessions, values averaged across sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start15 Apr 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499314
- Sponsor's protocol ID
- 17-00522
- Status last verified
- Feb 2022
- First submitted
- 9 Apr 2018
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03499314
- Acronym / sponsor ID
- 17-00522
- Conditions
- Multiple Sclerosis
- Keywords
- Anodal transcranial stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RS-tDCS Stimulation | Experimental | Device: Active RS-tDCS +At-Home Manual Dexterity Training, Other: Manual dexterity training20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee |
| Sham Stimulation | Placebo comparator | Device: Sham RS-tDCS +At-Home Manual Dexterity Training, Other: Manual dexterity training20 ×20-minute sessions sham tDCS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active RS-tDCS +At-Home Manual Dexterity TrainingBilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes | Device | RS-tDCS Stimulation |
| Sham RS-tDCS +At-Home Manual Dexterity TrainingDesigned to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds | Device | Sham Stimulation |
| Manual dexterity trainingManual 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. | Other | RS-tDCS Stimulation, Sham Stimulation |
Primary outcome
Mean Preload Phase Duration (PLD)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active RS-tDCS +At-Home Manual Dexterity Training and Manual dexterity training in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Preload Phase Duration (PLD) (time frame: baseline and 30 minutes for each of 20 sessions, values averaged across sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.