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| ID | Type | Description | Link |
|---|---|---|---|
| 15036-H19 | Other Grant/Funding Number | Louis Stokes Cleveland VA Medical Center IRB |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator | active tDCS plus gait training |
|
| Sham tDCS | Sham Comparator | sham tDCS plus gait training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svetlana Pundik, MD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40329808 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | active tDCS plus gait training 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 |
| FG001 | Sham tDCS | sham tDCS plus gait training 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | active tDCS plus gait training 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 |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Gait Speed From Baseline (Meters/Second) | Gait speed will be calculated based on Ten Meter Walk Test | Posted | Mean | Standard Deviation | meters/second | baseline to post treatment (after 5 weeks of treatment) |
|
adverse event information for each participant was collected during their study participation (baseline to 6 week follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | active tDCS plus gait training 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Svetlana Pundik | Department of Veterans Affairs Northeast Ohio Healthcare system | 216-791-3800 | 63732 | svetlana.pundik@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | Mar 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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transcranial Direct Current Stimulation
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|
| 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 |
|
|
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 |
sham tDCS plus gait training 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| years post stroke, mean (SD) | Mean | Standard Deviation | years |
|
| stroke type, Ischemic, n (count of participants) | Number | participants |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | baseline to post treatment (after 5 weeks of treatment) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | points | baseline to post treatment (after 5 weeks of treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | points | baseline to post treatment (after 5 weeks of treatment) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | points | baseline to post treatment (after 5 weeks of treatment) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline to after 5 weeks of treatment |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Sham tDCS | sham tDCS plus gait training 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 | 0 | 23 | 0 | 23 | 0 | 23 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |