Transcranial Direct Current Stimulation for Post-stroke Gait Rehab

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Gait Impairment
• Intervention / Treatment: Other: Active transcranial Direct Current Stimulation; Other: Sham transcranial Direct Current Stimulation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Speed From Baseline (Meters/Second)	Gait speed will be calculated based on Ten Meter Walk Test	baseline to post treatment (after 5 weeks of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Post Treatment on Timed up and go (Seconds)	Gait function measure where individuals rise from a chair, walk 3 meters, turn around and return to sitting in the chair	baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)	Functional gait measure where individuals walk under different conditions and are scored on a a 4 point scale for performance. 0-30 points; Higher score indicates better outcome	baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb	Motor control measure for lower limb after stroke, items rated on a scale of 0-2. A higher score indicates better outcome. score range is 0-34 points.	baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool	Measure of gait coordination after stroke; lower score indicates better coordination; 0-62 points, with lower score indicating better outcome	baseline to post treatment (after 5 weeks of treatment)
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline	Motor Evoked Potential (MEP) is a measure of corticospinal excitability using Transcranial Magnetic Stimulation. We collected maximum MEP from the paretic and non-paretic limbs. Asymmetry of paretic and non-paretic MEPs was calculated as follows: non-paretic minus paretic divided by a sum of paretic and non-paretic. It is expected that therapy reduces asymmetry caused by stroke. We report number of participants with reduced asymmetry of paretic and non-paretic tibialis anterior muscle Motor Evoked Potential.	baseline to after 5 weeks of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Motor Evoked Potentials from baseline	Measure of corticospinal excitability	at 1-4 days after completion of 10-session intervention protocol

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Svetlana Pundik, MD, Louis Stokes VA Medical Center, Cleveland, OH

Publications and helpful links

General Publications

• Pundik S, Skelly MM, McCabe JP, Salameh AI, Anderson T, Duncan KR, Hisel T, Carr SJA. Resting-State Functional Connectivity of Sensorimotor and Default Mode Networks and Lower Limb Performance in Chronic Stroke: A Cross-Sectional Study. Brain Behav. 2025 May;15(5):e70519. doi: 10.1002/brb3.70519.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Neuroplasticity; virtual reality; brain stimulation; transcranial Direct Current Stimulation (tDCS); walking ability; Gait therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: N2620-R; 15036-H19 (Other Grant/Funding Number: Louis Stokes Cleveland VA Medical Center IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No