Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Sep 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedStudy Start
First participant enrolled
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2024
CompletedResults Posted
Study results publicly available
June 10, 2025
CompletedSeptember 16, 2025
August 1, 2025
5.5 years
September 4, 2018
March 17, 2025
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change From Baseline to Post Treatment on Timed up and go (Seconds)
baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)
baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb
baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool
baseline to post treatment (after 5 weeks of treatment)
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline
baseline to after 5 weeks of treatment
Study Arms (2)
Active tDCS
ACTIVE COMPARATORactive tDCS plus gait training
Sham tDCS
SHAM COMPARATORsham tDCS plus gait training
Interventions
Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
Related Publications (1)
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.
PMID: 40329808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Svetlana Pundik
- Organization
- Department of Veterans Affairs Northeast Ohio Healthcare system
Study Officials
- PRINCIPAL INVESTIGATOR
Svetlana Pundik, MD
Louis Stokes VA Medical Center, Cleveland, OH
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 11, 2018
Study Start
September 13, 2018
Primary Completion
March 29, 2024
Study Completion
March 29, 2024
Last Updated
September 16, 2025
Results First Posted
June 10, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR