Improving movement after stroke using electrical spinal cord stimulation
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
NA · Shirley Ryan AbilityLab · NCT05167786
This study is testing if a new type of electrical stimulation combined with walking training can help people who have trouble moving after a stroke improve their walking and balance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05167786 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of non-invasive transcutaneous spinal cord stimulation combined with gait training for individuals with hemiplegia resulting from stroke. It includes a cross-over design and a randomized control trial to assess both short-term and long-term effects on gait symmetry, performance, and corticospinal circuitry. The study aims to identify optimal stimulation parameters and distinguish between responders and non-responders to the treatment. Participants will undergo tailored interventions to enhance their mobility and balance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are at least 6 months post-stroke and have hemiplegia from a single stroke.
Not a fit: Patients with multiple strokes, severe contractures, or those currently receiving regular physical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve gait and balance in individuals with hemiplegia due to stroke.
How similar studies have performed: Other studies have shown promise with similar non-invasive spinal stimulation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
- Study coordinator: Kelly McKenzie, DPT
- Email: kmckenzie@sralab.org
- Phone: 312-238-7111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke