Transcranial Direct Current Stimulation for Post-stroke Gait Rehab

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03666533

Collaborator

(none)

Enrollment

Location

Arms

48.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Unfortunately, current gait rehabilitation treatments are limited and many stroke survivors do not achieve full recovery. Therefore, it is critical to develop new approaches to enhance gait rehabilitation methods. The investigators propose to evaluate a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) that can be added to physical therapy. tDCS has been applied for arm rehabilitation after stroke with positive results, but gait-related investigations are lacking. The investigators will test whether simultaneous tDCS and gait training produces greater improvement in walking abilities than gait training alone. Adjunct tDCS therapy may improve outcomes, and reduce cost of both rehabilitation and post-stroke care.

Condition or Disease	Intervention/Treatment	Phase
Stroke Gait Impairment	Other: Active transcranial Direct Current Stimulation Other: Sham transcranial Direct Current Stimulation	Phase 2

Detailed Description

Current rehabilitation methods fail to restore normal gait for many stroke survivors leading to dependence on others, recurrent falls, limitations in community ambulation and poor quality of life. The main objective of this study is to test both efficacy and neurophysiological mechanisms of a novel approach to treat persistent gait deficits after stroke with a combination of simultaneous non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) and gait training. The investigators will enroll chronic stroke subjects (>6 months) with gait deficits. Subjects will be randomized to 10 sessions of either active tDCS+gait training or sham tDCS+gait training. Gait training will be accomplished in the treadmill-based Virtual Reality environment targeting longer single limb stance with the paretic limb. The primary outcome measure will be both gait speed and single limb stance duration. Other outcome measures will assess various components of gait-related functional domains. The study will also characterize neuroplastic brain changes in response to bihemispheric tDCS combined with gait training based on corticospinal excitability using motor evoked potentials and functional connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

transcranial Direct Current Stimulationtranscranial Direct Current Stimulation

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Transcranial Direct Current Stimulation for Post-stroke Gait Rehab

Actual Study Start Date :

Sep 13, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active tDCS active tDCS plus gait training	Other: Active transcranial Direct Current Stimulation Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy Other Names: tDCS
Sham Comparator: Sham tDCS sham tDCS plus gait training	Other: Sham transcranial Direct Current Stimulation Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy Other Names: Sham tDCS

Arm

Intervention/Treatment

Active Comparator: Active tDCS

active tDCS plus gait training

Other: Active transcranial Direct Current Stimulation

Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy

Other Names:

tDCS

Sham Comparator: Sham tDCS

sham tDCS plus gait training

Other: Sham transcranial Direct Current Stimulation

Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy

Other Names:

Sham tDCS

Outcome Measures

Primary Outcome Measures

Change in Gait Speed from baseline [at 1-4 days after completion of 10-session intervention protocol]
Gait speed will be calculated based on Ten Meter Walk Test

Other Outcome Measures

Change in Motor Evoked Potentials from baseline [at 1-4 days after completion of 10-session intervention protocol]
Measure of corticospinal excitability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Medically and psychologically stable and at least 6 months after first ever unilateral stroke
Cognition sufficiently intact to give valid informed consent to participate
FMLE score >15; and ability to actively dorsiflex the paretic ankle in synergy (FMLE item II Flexor synergy-ankle dorsiflexion score 1).
Sufficient endurance to participate in the study

Exclusion Criteria:

Activity tolerance is insufficient to complete treadmill training
Inability to produce a trace contraction of ankle dorsiflexors in synergy
Normal ankle dorsiflexion/knee flexion on FMLE standing items (FMLE item IV score=4)
Stroke affecting both sides
Contraindications for rTMS according to the most recent TMS-use guidelines
Contraindications for MRI
Inability to understand English