Transcranial Direct Current Stimulation for Post-stroke Gait Rehab

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03666533

Enrollment

Registered

2018-09-11

Start date

2018-09-13

Completion date

2024-03-29

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Impairment, Stroke

Keywords

Gait therapy, transcranial Direct Current Stimulation (tDCS), Neuroplasticity, walking ability, brain stimulation, virtual reality

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.

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).

Interventions

OTHERActive 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

OTHERSham 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

transcranial Direct Current Stimulation

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Gait Speed From Baseline (Meters/Second)	baseline to post treatment (after 5 weeks of treatment)	Gait speed will be calculated based on Ten Meter Walk Test

Secondary

Measure	Time frame	Description
Change From Baseline to Post Treatment on Timed up and go (Seconds)	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
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)	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
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb	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.
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool	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
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	21
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	23
Total	44

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	2

Baseline characteristics

Characteristic	Active tDCS	Sham tDCS	Total
Age, Continuous	62.5 years STANDARD_DEVIATION 10.7	67.7 years STANDARD_DEVIATION 8.3	65.2 years STANDARD_DEVIATION 10
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	21 Participants	23 Participants	44 Participants
Sex: Female, Male Female	8 Participants	4 Participants	12 Participants
Sex: Female, Male Male	13 Participants	19 Participants	32 Participants
stroke type, Ischemic, n (count of participants)	18 participants	16 participants	34 participants
years post stroke, mean (SD)	4.5 years STANDARD_DEVIATION 3.4	4.5 years STANDARD_DEVIATION 4.9	4.5 years STANDARD_DEVIATION 4.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 23
other Total, other adverse events	0 / 21	0 / 23
serious Total, serious adverse events	0 / 21	0 / 23