Using spinal cord stimulation to treat freezing of gait in Parkinson's disease
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
This study is testing if spinal cord stimulation can help people with Parkinson's disease who struggle with freezing of gait feel more stable and move better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06798844 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of spinal cord stimulation (SCS) for treating freezing of gait (FOG) in patients with Parkinson's disease (PD). It is a randomized, double-blind, placebo-controlled crossover trial involving 29 patients who will receive an implanted SCS lead connected to an external stimulator. Over a 3-week period, participants will experience three different stimulation paradigms, including a sham stimulation, while their FOG symptoms are assessed using wearable accelerometers and self-reported questionnaires. The study aims to evaluate the safety, optimal stimulation settings, and underlying mechanisms of SCS for FOG.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-79 with idiopathic Parkinson's disease who experience at least one episode of freezing of gait per day despite optimal medical or deep brain stimulation management.
Not a fit: Patients with other severe neurological or psychiatric disorders that may interfere with outcome assessments or those with contraindications to spinal cord stimulation surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients suffering from freezing of gait in Parkinson's disease.
How similar studies have performed: While spinal cord stimulation has shown promise in treating other conditions, this specific application for freezing of gait in Parkinson's disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of idiopathic PD in accordance with the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease * Optimal medical or DBS management for FOG, as evaluated by a movement disorder neurologist and programming expert. Stable PD medication and/or DBS settings for ≥ 1 month prior to baseline assessment and no changes are expected for the next 8 weeks * Self-reported FOG severity of ≥ 1 FOG episode per day, based on NFOG-Q items 1 and 2 * Presence of FOG during in-hospital clinical assessment consisting of 3 FOG-provoking tasks, in the on-medication state * Able to walk 10 meters unassisted without a walking aid (use of a cane is allowed) * Able to understand study requirements and provide consent * Age 40-79 years inclusive Exclusion Criteria: * Presence of other severe neurological, psychiatric or other disorder that may impede assessment of outcomes * Contra-indications to SCS surgery (e.g. epidural fibrosis, inability to safely discontinue anticoagulant drugs, allergy to implants, medically inoperable) * Cognitive impairment (Montreal Cognitive Assessment (MOCA) \<19/30) * Chronic (\>6m) severe (numeric rating scale \>5/10) back or leg pain, or FBSS, as the antalgic effect of SCS could cloud our interpretations for its effect on FOG * Duodopa pump or apomorphine injections * Fall frequency \>1x/day (this criterion comprises only 'actual falls', no 'near falls') * Absence of FOG during preoperative at-home FOG-protocol, in on- or off-medication assessment * Pregnancy, lactating or active pregnancy plans
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Philippe De Vloo, MD, PhD, Prof. — Department of Neurosurgery, University Hospitals Leuven
- Study coordinator: Sara Smeets, MD
- Email: sara.smeets@uzleuven.be
- Phone: +32 16 344290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.