Actively Recruiting
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-02-13
29
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Freezing of gait (FOG) is a disabling walking problem in Parkinson's disease (PD) that often does not respond well to current treatments. This study is a randomized, double-blind, placebo-controlled cross-over trial aiming to evaluate spinal cord stimulation (SCS) for FOG in PD patients. Researchers want to understand the effects, safety, best stimulation settings, and how SCS works by looking at clinical and neurophysiological data. Twenty-nine PD patients with difficult-to-treat FOG will have an SCS lead implanted connected to an external stimulator for a 3-week trial. Three stimulation types will be tested in random order: tonic SCS (causing sensation), DTM SCS (without sensation), and sham (no stimulation). Each type lasts 5 days with 2-day breaks in between. If patients improve, they may receive a permanent implanted stimulator and continue in a long-term open-label phase. Control groups include patients without PD or with PD but no FOG who also received SCS for other reasons. Participants will perform a home-based FOG-provoking protocol involving walking and daily tasks while wearing sensors and being video recorded. Assessments include questionnaires, gait analysis, and electrophysiological recordings of the spinal cord and brain activity in some patients. Follow-up evaluations occur at 6 months to assess long-term effects and safety. This study aims to improve understanding of FOG and support future use of SCS in clinical care.
CONDITIONS
Brief Title
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society criteria
- Stable medication and/or deep brain stimulation settings for at least 1 month before baseline
- Self-reported freezing of gait episodes at least once per day
- Presence of freezing of gait during clinical assessment on medication
- Able to walk 10 meters without a walking aid (cane use allowed)
- Able to understand study requirements and provide consent
- Age between 40 and 79 years inclusive
You will not qualify if you...
- Other severe neurological, psychiatric, or medical disorders affecting outcome assessment
- Contraindications to spinal cord stimulation surgery, including epidural fibrosis or inability to stop anticoagulants safely
- Cognitive impairment with MOCA score below 19/30
- Chronic severe back or leg pain lasting more than 6 months
- Use of Duodopa pump or apomorphine injections
- Falling more than once per day (actual falls only)
- No freezing of gait detected during preoperative home assessment
- Pregnancy, breastfeeding, or plans to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants undergo implantation of a spinal cord lead connected to an external stimulator for a 3-week trial period. During this time, three spinal cord stimulation paradigms (two active and one sham) are tested in randomized order with wash-out periods to evaluate effects on freezing of gait.
Visits at days 7, 14, and 21 post-implantation for assessments
Duration - Up to 1 week following trial stimulation
Based on clinical improvement during the trial stimulation, participants either receive a permanent implanted neurostimulator or have the trial electrode removed.
1 visit for decision and procedure
Duration - 6 months
Participants with a permanent implant and those without continue with long-term monitoring to assess safety and therapeutic efficacy of spinal cord stimulation for freezing of gait.
Follow-up visits including assessments at 6 months
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
S
Sara Smeets, MD
A
Amal El Kaddouri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here