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

NCT03658668 | Completed Results FDA Device

• 1 other identifier: 18-00534
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change in Gait Velocity

  Measured by a 10 meter walk test using wearable inertial sensors

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

• Change in Stride Length

  Measured by a 10 meter walk test using wearable inertial sensors

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

Secondary Outcomes (3)

• Percent of tDCS Sessions Completed

  End of Final Treatment Session (Up to Week 3)

• Change in 12-item Multiple Sclerosis Walking Scale Score

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

• Change 21-item Modified Fatigue Impact Scale Score

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

Study Arms (2)

active tDCS+PA

EXPERIMENTAL

Device: active tDCS; Other: Physical Activity (PA)

sham tDCS+PA

SHAM COMPARATOR

Device: sham tDCS; Other: Physical Activity (PA)

Interventions

active tDCS DEVICE

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

Also known as: Soterix 1x1 tDCS mini-CT

active tDCS+PA

sham tDCS DEVICE

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.

sham tDCS+PA

Physical Activity (PA) OTHER

20 minutes of cycling on an ergonomic cross-trainer

active tDCS+PA; sham tDCS+PA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 32431658 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Mathew Lustberg, MA
• Organization: NYU Langone Health

Matthew.Lustberg@nyulangone.org

929 445 5090

Study Officials

• Leigh Charvet, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: September 5, 2018
• Study Start: October 3, 2018
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Locations

US (1)