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

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.

Conditions

• Freezing of Gait
• Parkinson Disease

Interventions

DEVICE

Spinal Cord Stimulation

SCS is an established treatment for chronic neuropathic pain and the implantation procedure in this study follows the conventional clinical approach. Under local anaesthesia, a lead electrode is positioned in the spinal epidural space at the Th8-Th10 vertebral levels. The electrode is then connected to an external stimulator (implantable pulse generator, IPG), used for the 3-week external trial stimulation. Upon completion of the core trial, the electrode may either be removed or connected to an internal IPG, after extensive counselling and dependent on the FOG outcome and patient's preference. A subsequent long-term open label phase will evaluate the long-term efficacy and safety of SCS on FOG, with a follow-up period of six months. Electrophysiological recordings of the dorsal spinal cord will be conducted at the end of the external trial stimulation and at the 6-month follow-up.

OTHER

Spinal electrophysiological recordings

The sole purpose of the control groups in this study, is to facilitate the interpretation of spinal cord electrophysiological characteristics in PD freezers by providing a comparison with individuals without the condition.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Philippe De Vloo, MD, PhD, Prof. · Department of Neurosurgery, University Hospitals Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-28

Primary Completion

2027-05-31

Completion

2028-12-31

FDA Device

Yes

Countries

• Belgium

Study Locations