Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Post-stroke Gait Rehab (NCT NCT03666533)

NCT ID: NCT03666533

Last Updated: 2025-09-16

Results Overview

Gait speed will be calculated based on Ten Meter Walk Test

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: baseline to post treatment (after 5 weeks of treatment)
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	21	23
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active tDCS n=21 Participants 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	Sham tDCS n=23 Participants 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	Total n=44 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 10.7 • n=21 Participants	67.7 years STANDARD_DEVIATION 8.3 • n=23 Participants	65.2 years STANDARD_DEVIATION 10.0 • n=44 Participants
Sex: Female, Male Female	8 Participants n=21 Participants	4 Participants n=23 Participants	12 Participants n=44 Participants
Sex: Female, Male Male	13 Participants n=21 Participants	19 Participants n=23 Participants	32 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	21 Participants n=21 Participants	23 Participants n=23 Participants	44 Participants n=44 Participants
years post stroke, mean (SD)	4.5 years STANDARD_DEVIATION 3.4 • n=21 Participants	4.5 years STANDARD_DEVIATION 4.9 • n=23 Participants	4.5 years STANDARD_DEVIATION 4.2 • n=44 Participants
stroke type, Ischemic, n (count of participants)	18 participants n=21 Participants	16 participants n=23 Participants	34 participants n=44 Participants

PRIMARY outcome

Timeframe: baseline to post treatment (after 5 weeks of treatment)

Gait speed will be calculated based on Ten Meter Walk Test

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change in Gait Speed From Baseline (Meters/Second)	0.16 meters/second Standard Deviation 0.183	0.12 meters/second Standard Deviation 0.141

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change From Baseline to Post Treatment on Timed up and go (Seconds)	-6.93 seconds Standard Deviation 16.957	-5.7 seconds Standard Deviation 8.314

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)	2.79 points Standard Deviation 3.047	2.38 points Standard Deviation 1.717

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb	2.26 points Standard Deviation 1.996	2.62 points Standard Deviation 2.334

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool	-2.42 points Standard Deviation 2.219	-2.86 points Standard Deviation 2.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active tDCS n=19 Participants 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	Sham tDCS n=21 Participants 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
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline	9 Participants	8 Participants

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Svetlana Pundik

Department of Veterans Affairs Northeast Ohio Healthcare system

Phone: 216-791-3800

Email: svetlana.pundik@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place