Non-invasive spinal cord stimulation for improving gait in Parkinson's disease
Rehabilitation of Locomotor Function in Parkinson's Disease by Non-invasive Spinal Cord Stimulation
This study is testing whether a new non-invasive spinal cord stimulation can help people with Parkinson's disease walk better when their usual medication isn't working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06804642 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of non-invasive spinal cord transcutaneous stimulation (scTS) to improve gait dysfunction in patients with Parkinson's disease. By targeting multiple spinal levels, the study aims to activate locomotor central pattern generators that are disrupted in Parkinson's disease. The approach seeks to provide an alternative to invasive spinal cord stimulation, which has limitations such as fixed stimulation sites and surgical risks. Participants will undergo scTS to assess its effectiveness in alleviating levodopa-resistant axial motor symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of Parkinson's disease who can ambulate 10 meters.
Not a fit: Patients with co-morbidities affecting gait or significant cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve gait and mobility for patients with Parkinson's disease.
How similar studies have performed: While few studies have explored spinal cord stimulation for Parkinson's gait symptoms, this non-invasive approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease; * Adults aged 18 to 80 years; * Competent to give informed consent for the research protocol; * Able to understand instructions; * Able to ambulate 10-meters. Exclusion Criteria: * Co-morbidities affecting gait; * Clinically significant cognitive dysfunction; * Clinically significant depression or major active psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder; * Terminal illness associated with \<12-month survival; * Have a current diagnosis or condition such as major cardiac insufficiency, determined clinically by the study doctors; * Current alcohol or substance abuse that is uncontrolled or unmanageable; * Individuals unable to communicate with the investigator and study staff; and/or * Individuals with any illness that, in the study doctors' opinion, may preclude them from spinal cord transcutaneous stimulation, activity-based recovery training, or participation in study assessments.
Where this trial is running
Louisville, Kentucky
- Frazier Rehab Institute — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Andrea Wilhite, MS
- Email: andrea.willhite@louisville.edu
- Phone: 5025874871
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.