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

Plain-Language Summary

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.

View on ClinicalTrials.gov