Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT05167786
- Run by
- Shirley Ryan AbilityLab
- People needed
- 115
- Starts
- 2022-03-01
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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