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Completed

NCT Number: NCT03666533

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Impairment Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active transcranial Direct Current Stimulation

Other

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 transcranial direct current stimulation

Other

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

Primary outcomes

  1. Change in Gait Speed From Baseline (Meters/Second)

    Time frame: baseline to post treatment (after 5 weeks of treatment)

    Gait speed will be calculated based on Ten Meter Walk Test

Secondary outcomes

  1. Change From Baseline to Post Treatment on Timed up and go (Seconds)

    Time frame: baseline to post treatment (after 5 weeks of treatment)

    Gait function measure where individuals rise from a chair, walk 3 meters, turn around and return to sitting in the chair

  2. Change From Baseline to Post Treatment in Functional Gait Assessment (Points)

    Time frame: baseline to post treatment (after 5 weeks of treatment)

    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

  3. Change From Baseline to Post Treatment on Fugl Meyer Lower Limb

    Time frame: baseline to post treatment (after 5 weeks of treatment)

    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.

  4. Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool

    Time frame: baseline to post treatment (after 5 weeks of treatment)

    Measure of gait coordination after stroke; lower score indicates better coordination; 0-62 points, with lower score indicating better outcome

  5. Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline

    Time frame: baseline to after 5 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2018
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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