Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- Noninvasive spinal stimulation with gait training (device)
- Conventional gait training (device)
- Exploratory Phase - Optimization of Gait Training and Spinal Stimulation (other)
Sponsor: Shirley Ryan AbilityLab · Participants: 115 · Started: Mar 1, 2022
Contact the study team
- Kelly McKenzie, DPT · Phone: 312-238-7111
- Sara Prokup, DPT · Phone: 3122381355
Official record on ClinicalTrials.gov — NCT05167786
Locations in the U.S.
| Illinois | Shirley Ryan AbilityLab, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.