Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis

NCT03757819 | Completed Results FDA Device

• 1 other identifier: 201810705
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Many of the current treatments, including pharmaceuticals, are only mildly effective and are often very expensive. Thus, the development of practical, inexpensive, and effective adjunct treatments is needed. The study is to examine the efficacy of different tDCS protocols at improving walking in PwMS. Although the details of the studies slightly vary, the global aspects of the experimental procedures are identical with the exception that the tDCS stimulation parameter timing differs between the groups. The study will be double-blind, sham-controlled, randomized cross-over design. Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg. The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and a 6 minute walk test (6-MWT) for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURINGtDCS, DURINGSHAM. Group 2: BEFOREtDCS, BEFORESHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham, which results in after effects lasting through the completion of the 6 MWT. tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg either before or during the 6 min walk test

Conditions

Transcranial Direct Current Stimulation

Keywords

Multiple Scerosis

Outcome Measures

Primary Outcomes (2)

• Distance Walked on a Treadmill With tDCS

  6 min walk test

  one week

• Distance Walked on a Treadmill With SHAM

  6 min walk test

  one week

Other Outcomes (1)

• Leg Strength Data

  one week

Study Arms (2)

Before Walking tDCS first then SHAM

EXPERIMENTAL

To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.

Device: tDCS; Device: SHAM

During Walking tDCS first then SHAM

EXPERIMENTAL

To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.

Device: tDCS; Device: SHAM

Interventions

tDCS DEVICE

Brain Stimulation

Before Walking tDCS first then SHAM; During Walking tDCS first then SHAM

SHAM DEVICE

Placebo device

Before Walking tDCS first then SHAM; During Walking tDCS first then SHAM

Eligibility Criteria

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

You may qualify if:

• medically diagnosed with Multiple Sclerosis,
• moderate disability (Patient Determined Disease Steps (PDDS) core 2-6), -self-- reported differences in function between legs, able to walk for 6min. -

You may not qualify if:

• relapse within last 60 days,
• high risk for cardiovascular disease (ACSM risk classification),
• changes in disease modifying medications within last 45 days,
• concurrent neurological/neuromuscular disease,
• hospitalization within last 90 days,
• diagnosed depression, inability to understand/sign informed consent.

Sponsors & Collaborators

• Thorsten Rudroff: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Workman CD, Kamholz J, Rudroff T. Transcranial Direct Current Stimulation (tDCS) to Improve Gait in Multiple Sclerosis: A Timing Window Comparison. Front Hum Neurosci. 2019 Nov 28;13:420. doi: 10.3389/fnhum.2019.00420. eCollection 2019.

  PMID: 31849628 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Thorsten Rudroff
• Organization: University of Iowa

thorsten-rudroff@uiowa.edu

17205323701

Study Officials

• Thorsten Rudroff

  University of Iowa

  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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study employed a double-blind, sham-controlled, parallel-randomized crossover design. Each participant attended three sessions. In the first session, participants were consented and completed the Patient-Determined Disease State and Fatigue Severity Scale questionnaires. Then, after a counter-balanced randomization into BEFORE or DURING groups, the participants completed a 6-Minute Walk Test for baseline/familiarization purposes. The second and third sessions involved brain stimulation or sham stimulation either before or during a 6-Minute Walk Test, depending on group assignment. The brain stimulation was randomly assigned to either session two or three, and sham stimulation was performed in the other session.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: February 25, 2019
• Primary Completion: July 7, 2019
• Study Completion: July 7, 2019
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)