Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis

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: NCT03658668
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA)


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: active tDCS Device: sham tDCS Other: Physical Activity (PA) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active tDCS+PA Device: active tDCS
tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.
Other Name: Soterix 1x1 tDCS mini-CT

Other: Physical Activity (PA)
20 minutes of cycling on an ergonomic cross-trainer

Sham Comparator: sham tDCS+PA Device: sham tDCS
During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then againat the end of the session. These brief periods of stimulation serveto mimic the effects of a true stimulation session.

Other: Physical Activity (PA)
20 minutes of cycling on an ergonomic cross-trainer




Primary Outcome Measures :
  1. Gait Velocity [ Time Frame: Baseline ]
    Measured by a 10 meter walk test using wearable inertial sensors

  2. Stride Length [ Time Frame: 4 Weeks ]
    Measured by a 10 meter walk test using wearable inertial sensors

  3. Gait Velocity [ Time Frame: 4 Weeks ]
    Measured by a 10 meter walk test using wearable inertial sensors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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, subtype relapsing-remitting (RR-MS)
  • Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
  • Clinically stable and stable on treatment with disease modifying agents at least from 6 months
  • Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
  • Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
  • Able to use study equipment
  • Able to commit 5 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
  • Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

  • Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
  • Primary psychiatric disorder that would influence ability to participate
  • Receiving current treatment for epilepsy
  • Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
  • History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
  • Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
  • Treatment for a communicable skin disorder currently or over the past 12 months
  • History of uncontrolled or labile hypertension
  • Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
  • Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score < 85
  • History of clinically significant abnormalities on electrocardiogram (EKG)
  • Presence of chronic medical illness and/or severe ataxia
  • Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
  • Alcohol or other substance use disorder
  • Pregnant or breastfeeding

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): NCT03658668


Contacts
Layout table for location contacts
Contact: Mathew Lustberg, MA 929 445 5090 Matthew.Lustberg@nyulangone.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Mathew Lustberg, MA    929-445-5090    Matthew.Lustberg@nyulangone.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Leigh Charvet, MD NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03658668     History of Changes
Other Study ID Numbers: 18-00534
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases