Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease

Not Applicable

Completed

• Conditions: Gait Disorders, Neurologic; Parkinson Disease
• Interventions: Procedure: Implantation of electrodes for Spinal cord stimulation

• Registration Number: NCT04682678
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.

Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.

Detailed Description

Patients will be selected in the Movement Disorders Unit, Department of Neurology, University Hospital Grenoble. A preoperative assessment with gait assessment, clinical evaluation and Non-Motor Symptoms assessment will be realized. The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.After the first post-operative month the patient will be randomized to the STIM ON condition (stimulation on, with the most effective parameters) or STIM OFF (without stimulation). The randomization will be performed in a double blinded fashion, by a neurologist working in open and not participating in the evaluations. After 3 months, the patient will be evaluated in a double blind condition, and the stimulation condition will be crossed for another period of 3 months. At the end of this second 3-month period, the patient will be again double-blind assessed. After this evaluation, the patient will enter the open phase of the study for a period of 6 months. For this last phase of the study, under STIM ON condition, an optimization of the stimulation settings will be realized, if necessary. At the end of this 6-month period of stimulation, the patient will be evaluated one last time. At all visits, clinical and gait evaluations will be carried out under chronic dopaminergic treatment. No change in antiparkinsonian treatment will be allowed during the entire study. Gait and clinical assessment will be performed at baseline and at the end of each double blinded phase and at 1-year follow-up. For the double-blind study the patient, the neurologist who performs the clinical evaluation and the expert who performs the gait test and analysis will be blind to the stimulation condition.

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-24
• Study Start: 2021-03-10
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ON STIM	Implantation of electrodes for Spinal cord stimulation	stimulation with the most effective parameters
OFF STIM	Implantation of electrodes for Spinal cord stimulation	without stimulation

Primary Outcome Measures

Name	Time	Method
frequency and duration of Freezing Of Gait (FOG) episodes, objective	Month 6	gait testing

Secondary Outcome Measures

Name	Time	Method
impact of SCS on gait during timed up and go test	Month 12	timed up and go test
impact of spinal cord stimulation on FOG, long term outcome	Month 12	New Freezing Of Gait-questionnaire (NFOG-Q)
impact of spinal cord stimulation on quality of life, long term outcome	Month 12	Parkinsons disease questionnaire (PDQ39)
impact of SCS on gait during a dual cognitive-motor task test	Month 12	New FOG-questionnaire (NFOG-Q)
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 2	Month 12	patient diary
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 1	Month 12	New FOG-questionnaire (NFOG-Q)
impact of SCS on other non-motor symptoms	Month 12	SCales for Outcomes in PArkinson's disease - Autonomic Dysfunction (SCOPA-AUT)

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France