Recruiting

Transcutaneous Electrical Spinal Cord StimulationLocomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05167786

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Noninvasive spinal stimulation with gait training

Conventional gait training

Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Study Details

Brief summary:

This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

Conditions

Stroke

Study ID

NCT05167786

Start date

Mar 1, 2022

Status verified date

Mar, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

Age 18 years or older
Able and willing to give written consent and comply with study procedures
At least 6 months' post-stroke
Hemiplegia secondary to a single stroke
Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
Not currently receiving regular physical therapy services
Physician approval to participate

Exclusion Criteria

Ataxia
Multiple stroke history
Botox injection in lower extremity within the last 4 months
Modified Ashworth score of 3 or greater in lower extremity
Pregnant or nursing
Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
Active pressure sores
Unhealed bone fractures
Peripheral neuropathies
Painful musculoskeletal dysfunction due to active injuries or infections
Severe contractures in the lower extremities
Medical illness limiting the ability to walk
Active urinary tract infection
Clinically significant depression, psychiatric disorders, or ongoing drug abuse
Active cancer or cancer in remission less than 5 years
Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
Traumatic brain injury or other neurological conditions that would impact the study.

TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will participate in this component of the studies.

Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
Implanted cardiac pacemaker
Metal implants in the head or face
Suffers unexplained, recurring headaches
Had a seizure in the past unrelated to the stroke event, or has epilepsy
Skull abnormalities or fractures
A concussion within the last 6 months
Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)

Study Design

Enrollment

115 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aim 1: Gait Training + Stimulation

Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

active comparator: Aim 1: Gait Training + Sham Stimulation

Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

experimental: Aim 2: Gait Training + Stimulation

active comparator: Aim 2: Gait Training + Sham Stimulation

Interventions

Noninvasive spinal stimulation with gait training

Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.

Conventional gait training

Subjects will receive lower limb locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Subjects may receive various lower limb locomotion training with or without transcutaneous spinal cord stimulation. Training approaches may include but are not limited to single or split belt treadmill and over ground walking. Transcutaneous Spinal Cord Neurostimulator may deliver a variety of transcutaneous electrical spinal cord stimulation to subjects.

Primary outcome measure

Change in Gait Symmetry [ Time Frame: Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2. ]

Central Contacts and Locations

Central contacts

Kelly McKenzie, DPT

312-238-7111 kmckenzie@sralab.org

Sara Prokup, DPT

3122381355 sprokup@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kelly McKenzie, DPT

312-238-7111 kmckenzie@sralab.org

Shreya Aalla, BS

312-238-7323 saalla@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-03-17.