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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of spinal cord stimulation (SCS) to help people with Parkinson's disease who experience a condition called freezing of gait (FOG). FOG can make it difficult for individuals to move or walk, which significantly impacts their daily lives. Researchers want to see if SCS can improve FOG symptoms by examining how different stimulation methods work over a three-week period. Participants will wear special devices to track their movements and will complete surveys about their experiences. This trial aims to gather important information about the safety and effectiveness of SCS and to understand how it might help those suffering from FOG.

To be eligible for this study, participants must be between 40 and 79 years old, have a confirmed diagnosis of Parkinson's disease, and experience at least one episode of FOG each day. They should also be stable on their medication or deep brain stimulation settings for at least a month before joining the trial. Participants will receive a spinal cord stimulator for testing, and those who find it helpful may have the opportunity for a permanent implant later on. This research could lead to better treatment options for people with FOG and improve their quality of life.

Gender

ALL

Eligibility 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