Spinal cord transcutaneous stimula… for Parkinson's (NCT06804642)
Improve walking with spinal stimulation
- Trial ID
- NCT06804642
- Official Title
- Rehabilitation of Locomotor Function in Parkinson's Disease by Non-invasive Spinal Cord Stimulation
- Goal
- Improve walking with spinal stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Louisville
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson Disease
- Interventions
- Spinal cord transcutaneous stimulation (scTS)
Summary For Families
The goal is to improve walking and balance in people with Parkinson's, targeting problems like shuffling, poor coordination, and trouble initiating steps. The approach uses non-invasive spinal cord transcutaneous stimulation, delivering mild electrical pulses through the skin over the lower back to change how spinal networks shape stepping and boost coordination and endurance during gait, often paired with walking practice to reinforce improvements. It is a device-based rehab technique rather than a drug, so it aims to retrain nervous system control of walking. The trial is looking for adults 18 to 80 with Parkinson's who can walk 10 meters and give informed consent, and it excludes people with other major health problems that affect gait, serious cognitive or psychiatric conditions, uncontrolled substance abuse, or anything that would make stimulation unsafe.
Locations
- Frazier Rehab Institute, Louisville, Kentucky, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Spinal cord transcutaneous stimulation (scTS). The goal is to improve walking and balance in people with Parkinson's, targeting problems like shuffling, poor coordination, and trouble initiating steps. The approach uses non-invasive spinal cord transcutaneous stimulation, delivering mild electrical pulses through the skin over the lower back to change how spinal networks shape stepping and boost coordination and endurance during gait, often paired with walking practice to reinforce improvements. It is a device-based rehab technique rather than a drug, so it aims to retrain nervous system control of walking. The trial is looking for adults 18 to 80 with Parkinson's who can walk 10 meters and give informed consent, and it excludes people with other major health problems that affect gait, serious cognitive or psychiatric conditions, uncontrolled substance abuse, or anything that would make stimulation unsafe.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 years.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- You will take part in multiple assessment and intervention sessions over a 9-12 month period; intervention training sessions last approximately 2 hours and are held 3 days per week to achieve at least 12 sessions (1-month) or 24 sessions (2-month).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.