Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Freezing of gait (FOG) is a severely disabling gait disorder in Parkinson's disease (PD). Its poor response to current therapies reflects the shortfall in current knowledge on its exact pathophysiology. Case series suggest a therapeutic promise of spinal cord stimulation (SCS) for FOG, but double-blind randomised controlled trials with reliable FOG assessments are lacking. This randomised, double-blind, placebo-controlled cross-over trial aims to define the outcome, safety, optimal stimulation paradigm and underlying mechanism of SCS for FOG in PD, by exploring both clinical and neurophysiological parameters. Twenty-nine PD patients with refractory FOG will receive an implanted SCS lead connected to an external trial stimulator. During a 3-week trial, 3 stimulation paradigms will be tested in random order, including one sham paradigm. SCS outcome on FOG will be evaluated through wearable accelerometers, self-reported questionnaires and a FOG-provoking protocol at home. Spinal electrophysiological recordings will compare neural properties between PD patients with and without FOG and evaluate intra-patient differences (e.g., on/off medication, DBS states). In patients with deep brain stimulation (DBS) including BrainSense technology, the effect of SCS on pathological beta oscillations in the STN will be explored. A subsequent long-term open-label phase will be conducted in those patients who desire a definitive implanted stimulator. This project will provide new insights into the pathophysiology of FOG, pave the way for SCS implementation in clinical practice and enhance future patient selection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Contact Information
Primary
Sara Smeets, MD
sara.smeets@uzleuven.be
+32 16 344290
Backup
Amal El Kaddouri
amal.elkaddouri@uzleuven.be
+32 16 344801
Time Frame
Start Date: 2025-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 29
Treatments
Experimental: PD patients with refractory FOG
29 PD patients with refractory FOG will receive a 3-week SCS trial with an implanted lead connected to an external stimulator, during which two SCS paradigms (one with and one without paraesthesia) and a sham paradigm will be compared. If a clinically relevant improvement in FOG or gait is perceived during the external trial stimulation, the participant will receive a permanent implanted neurostimulator.
Other: Control group 1: SCS patients without PD
± 15 patients without PD who received SCS for FBSS outside research settings.~To evaluate the secondary exploratory outcome on spinal cord electrophysiology in PD freezers, two control groups of SCS patients treated for approved indications outside research settings will be included. This allows for an exploratory, non-blinded, and non-randomized comparison of spinal cord electrophysiological characteristics between patients with PD and FOG (intervention group), without PD (control group 1) and with PD without FOG (control group 2).
Other: Control group 2: SCS patients with PD, without FOG
Max. 5 patients with PD without FOG who received SCS for FBSS outside research settings.~To evaluate the secondary exploratory outcome on spinal cord electrophysiology in PD freezers, two control groups of SCS patients treated for approved indications outside research settings will be included. This allows for an exploratory, non-blinded, and non-randomized comparison of spinal cord electrophysiological characteristics between patients with PD and FOG (intervention group), without PD (control group 1) and with PD without FOG (control group 2).
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov