Spinal Cord Stimulation for Parkinson's (NCT06798844)
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?
- 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 Phase 2 trial is estimated to last approximately 2 years and 3 months.
- 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?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.