Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease (SCM-PARK)

Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Gait Disorders, Neurologic
• Intervention / Treatment: Procedure: Implantation of electrodes for Spinal cord stimulation

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Patients with diagnosis of idiopathic PD
2. Aged 50-85 years
3. Having a FOG (score> 14 at New-FOG-Questionnaire; score> = 1 at item 2.13 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale) despite the optimization of medical treatment
4. Drug treatment stable for at least 2 months
5. Able to give written consent.

Exclusion criteria:

1. Pain syndrome (score> = 2 at item 1.9 of the MDS-UPDRS II)
2. Psychosis
3. Severe depression
4. Severe cognitive impairment (Mini Mental Score Examination <19)
5. Patient receiving STN DBS treatment
6. Presence of other neurological or medical pathologies interfering with walking
7. Subject in period of exclusion from another study
8. Subject under administrative or judicial supervision
9. Subject who cannot be contacted in an emergency.
10. Person with any administrative or judicial measure of deprivation of rights and liberty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: OFF STIM; without stimulation	Procedure: Implantation of electrodes for Spinal cord stimulation; 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 (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.
Active Comparator: ON STIM; stimulation with the most effective parameters	Procedure: Implantation of electrodes for Spinal cord stimulation; 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 (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency and duration of Freezing Of Gait (FOG) episodes, objective	gait testing	Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Elena MORO, CHUGA

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 38RC20.165; 2020-A02361-38 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No