Non-invasive spinal stimulation to improve walking in neurological patients
Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
This study is testing if non-invasive spinal stimulation can help people with neurological disorders improve their walking ability when combined with gait training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 70 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04467437 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of non-invasive spinal cord stimulation on walking function in individuals with neurological disorders, such as cerebral palsy and stroke. Participants will undergo a cross-over design where they will receive intensive gait training either alone or combined with spinal stimulation. The study aims to assess the impact of this stimulation on spasticity and locomotor function, as well as gather participant feedback on their experiences. The intervention will last up to 11 months, with participants attending up to five sessions per week.
Who should consider this trial
Good fit: Ideal candidates include individuals with neurological conditions who can walk 20 yards and are capable of participating in physical therapy sessions.
Not a fit: Patients with significant medical diseases or conditions that prevent full participation in physical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking abilities and overall mobility for patients with neurological conditions.
How similar studies have performed: Previous studies have shown positive outcomes with spinal stimulation in spinal cord injury patients, suggesting potential for success in similar neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * have a neurologic condition * can walk 20 yards, with or without an assistive device * have stable medical condition * are capable of performing simple cued motor tasks and who can follow 2-3 step commands * have ability to attend up to 5 sessions per week physical therapy sessions and testing activities * have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period. * who are volunteering to be involved in this study * can read and speak English Exclusion Criteria: * have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation. * have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention * have a history of uncontrolled seizures * have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities * are dependent on ventilation support * have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump) * have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months * have established osteoporosis and taking medication for osteoporosis treatment. * have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) * have active cancer
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Katherine M Steele, PhD — University of Washington
- Study coordinator: Siddhi R Shrivastav, BPTh, MS
- Email: siddhis@uw.edu
- Phone: 973-444-1940
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.