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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

active tDCS

sham tDCS

Physical Activity (PA)

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stable and continuous access to internet service at home
Adequate home facilities (enough space, access to quiet and distraction free area)
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 10 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

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS+PA

sham tDCS+PA

Arm Description

Outcomes

Primary Outcome Measures

Change in Gait Velocity

Measured by a 10 meter walk test using wearable inertial sensors

Change in Stride Length

Measured by a 10 meter walk test using wearable inertial sensors

Secondary Outcome Measures

Percent of tDCS Sessions Completed

Change in 12-item Multiple Sclerosis Walking Scale Score

12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.

Change 21-item Modified Fatigue Impact Scale Score

21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.

Full Information

NCT ID

NCT03658668

First Posted

August 14, 2018

Last Updated

July 25, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03658668

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 3, 2018 (Actual)

Primary Completion Date

June 10, 2021 (Actual)

Study Completion Date

June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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). Portions of this study may be completed remotely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

active tDCS+PA

Arm Type

Experimental

Arm Title

sham tDCS+PA

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

active tDCS

Other Intervention Name(s)

Soterix 1x1 tDCS mini-CT

Intervention Description

tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.

Intervention Type

Device

Intervention Name(s)

sham tDCS

Intervention Description

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 again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.

Intervention Type

Other

Intervention Name(s)

Physical Activity (PA)

Intervention Description

20 minutes of cycling on an ergonomic cross-trainer

Primary Outcome Measure Information:

Title

Change in Gait Velocity

Description

Measured by a 10 meter walk test using wearable inertial sensors

Time Frame

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Title

Change in Stride Length

Description

Measured by a 10 meter walk test using wearable inertial sensors

Time Frame

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Secondary Outcome Measure Information:

Title

Percent of tDCS Sessions Completed

Time Frame

End of Final Treatment Session (Up to Week 3)

Title

Change in 12-item Multiple Sclerosis Walking Scale Score

Description

Time Frame

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Title

Change 21-item Modified Fatigue Impact Scale Score

Description

Time Frame

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable and continuous access to internet service at home Adequate home facilities (enough space, access to quiet and distraction free area) 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 10 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leigh Charvet, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32431658

Citation

Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.

Results Reference

derived

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

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