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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RS-tDCS Stimulation | Experimental | 20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee |
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| Sham Stimulation | Placebo Comparator | 20 ×20-minute sessions sham tDCS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active RS-tDCS +At-Home Manual Dexterity Training | Device | Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 30 minutes for each of 20 sessions, values averaged across sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 |
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| Sham RS-tDCS +At-Home Manual Dexterity Training | Device | Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds |
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| Manual dexterity training | Other | 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. |
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| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | baseline and 30 minutes for each of 20 sessions, values averaged across sessions |
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1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 33 | 0 | 33 | 24 | 33 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 22 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Tingling | General disorders | Non-systematic Assessment | Skin Paresthesia |
| |
| Skin Itching | General disorders | Non-systematic Assessment | Skin Paresthesia |
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| Skin Warming | General disorders | Non-systematic Assessment | Skin Paresthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | (929) 455-5141 | Leigh.Charvet@nyulangone.org |
| Dec 22, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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