Spinal cord stimulation reduces freezing
- Trial ID
- NCT06798844
- Official Title
- Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
- Goal
- Spinal cord stimulation reduces freezing
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Study Type
- INTERVENTIONAL
- Enrollment
- 29 participants
- Conditions
- Freezing of Gait, Parkinson Disease
- Interventions
- Spinal Cord Stimulation, Spinal electrophysiological recordings
Summary For Families
The aim is to reduce freezing of gait, those sudden stops or hesitations that make walking unsafe or unpredictable for people with Parkinson's. An implanted spinal cord stimulator delivers mild electrical pulses to the dorsal spinal cord to modulate sensory and motor signals and help restore stepping rhythm, and the team will record spinal electrophysiology to see how those signals change. The device is tested as an add-on while people stay on stable Parkinson's medications or deep brain stimulation settings, so it does not replace levodopa or DBS but may provide extra control over gait. They are enrolling people 40 to 79 with idiopathic PD who have at least one daily freezing episode, can walk 10 meters unassisted, have reasonably preserved cognition (MoCA ≥19), and are medically eligible for SCS surgery; frequent daily fallers, those with severe chronic back pain or infusion pumps, and people with surgical contraindications are excluded.
Locations
- University Hospitals Leuven, Leuven, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Spinal Cord Stimulation. The aim is to reduce freezing of gait, those sudden stops or hesitations that make walking unsafe or unpredictable for people with Parkinson's. An implanted spinal cord stimulator delivers mild electrical pulses to the dorsal spinal cord to modulate sensory and motor signals and help restore stepping rhythm, and the team will record spinal electrophysiology to see how those signals change. The device is tested as an add-on while people stay on stable Parkinson's medications or deep brain stimulation settings, so it does not replace levodopa or DBS but may provide extra control over gait. They are enrolling people 40 to 79 with idiopathic PD who have at least one daily freezing episode, can walk 10 meters unassisted, have reasonably preserved cognition (MoCA ≥19), and are medically eligible for SCS surgery; frequent daily fallers, those with severe chronic back pain or infusion pumps, and people with surgical contraindications are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.