NCT05167786Recruiting
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 7 Dec 2021
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Shirley Ryan AbilityLab
- Diseases
- Stroke
- NCT number
- NCT05167786
What you commit to
- Study type: Interventional
- Planned participants: 115
- From 1 Mar 2022 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
- Metal implants in the head or face
Other illness
- Multiple stroke history
- Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
- Painful musculoskeletal dysfunction due to active injuries or infections
- 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
- 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.
- Implanted cardiac pacemaker
- Had a seizure in the past unrelated to the stroke event, or has epilepsy
- Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
Other
- Ataxia
- Botox injection in lower extremity within the last 4 months
- Modified Ashworth score of 3 or greater in lower extremity
- Pregnant or nursing
- Active pressure sores
- Unhealed bone fractures
- Peripheral neuropathies
- Severe contractures in the lower extremities
- Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
- Suffers unexplained, recurring headaches
- Skull abnormalities or fractures
- A concussion within the last 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shirley Ryan AbilityLab Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.