StrokeNCT03666533
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
A study testing Active transcranial Direct Current Stimulation in people with Stroke and Gait Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait Impairment
- What is being tested?
- Active transcranial Direct Current Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
About this study
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.
Read the 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).
- Conditions
- Stroke, Gait Impairment
- Being tested
- Active transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation
- Keywords
- Gait therapy, transcranial Direct Current Stimulation (tDCS), Neuroplasticity, walking ability, brain stimulation, virtual reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial Direct Current StimulationOther
Also called tDCS
Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Sham transcranial Direct Current StimulationOther
Also called Sham tDCS
Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | active tDCS plus gait training Receives: Other: Active transcranial Direct Current Stimulation |
| Sham tDCS | Sham comparator | sham tDCS plus gait training Receives: Other: Sham transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed From Baseline (Meters/Second)
Gait speed will be calculated based on Ten Meter Walk Test
Measured: baseline to post treatment (after 5 weeks of treatment)
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline to after 5 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start13 Sep 2018
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- transcranial Direct Current Stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Svetlana Pundik, MD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666533
- Sponsor's protocol ID
- N2620-R
- Other IDs
- 15036-H19
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2018
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 40329808
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
- ClinicalTrials.gov ID
- NCT03666533
- Acronym / sponsor ID
- N2620-R
- Conditions
- Stroke, Gait Impairment
- Keywords
- Gait therapy, transcranial Direct Current Stimulation (tDCS), Neuroplasticity, walking ability, brain stimulation, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- transcranial Direct Current Stimulation
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Other: Active transcranial Direct Current Stimulationactive tDCS plus gait training |
| Sham tDCS | Sham comparator | Other: Sham transcranial Direct Current Stimulationsham tDCS plus gait training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial Direct Current StimulationAlso: tDCSActive tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy | Other | Active tDCS |
| Sham transcranial Direct Current StimulationAlso: Sham tDCSSham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy | Other | Sham tDCS |
Primary outcome
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
5 secondary outcomes
Change From Baseline to Post Treatment on Timed up and go (Seconds)
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline
Time frame: baseline to after 5 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40329808Pundik 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Pundik, MD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial Direct Current Stimulation in people with Stroke and Gait Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed From Baseline (Meters/Second) (time frame: baseline to post treatment (after 5 weeks of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.