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Trial record 101 of 346 for:    Recruiting Studies | Multiple Sclerosis

A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499314
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Active RS-tDCS +At-Home Manual Dexterity Training Device: Sham RS-tDCS +At-Home Manual Dexterity Training Other: Manual dexterity training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Device: Active RS-tDCS +At-Home Manual Dexterity Training
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes

Other: 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.

Placebo Comparator: Sham Stimulation
20 ×20-minute sessions sham tDCS
Device: Sham RS-tDCS +At-Home Manual Dexterity Training
Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds

Other: 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.




Primary Outcome Measures :
  1. Temporal coordination between grasping and lifting force using the preload phase duration (PLD) [ Time Frame: 30 Minutes ]
    (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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499314


Contacts
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Contact: Guadalupe Zuniga-estrada 1 646 501 7506 Guadalupe.Zuniga-Estrada@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Guadalupe Zuniga-Estrada    646-501-7506    Guadalupe.Zuniga-Estrada@nyumc.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leigh Charvet, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03499314    
Other Study ID Numbers: 17-00522
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by NYU Langone Health:
Anodal transcranial stimulation (tDCS)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases