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

• ClinicalTrials.gov Identifier: NCT04682678
• Recruitment Status: Recruiting
• First Posted: December 24, 2020
• Last Update Posted: February 1, 2021
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Gait Disorders, Neurologic	Procedure: Implantation of electrodes for Spinal cord stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study
• Actual Study Start Date: January 29, 2021
• Estimated Primary Completion Date: January 28, 2022
• Estimated Study Completion Date: January 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. frequency and duration of Freezing Of Gait (FOG) episodes, objective [ Time Frame: Month 6 ]
   gait testing

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Andrea KISTNER; **33 ext 476767575; akistner@chu-grenoble.fr

Locations

France

Chu Grenoble Alpes; Recruiting

Grenoble, France, 38043

Contact: KISTNER Andréa 33 (0)4 76 76 94 59 AKistner@chu-grenoble.fr

Principal Investigator: MORO Elena

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

• Principal Investigator: Elena MORO; CHUGA

More Information

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04682678
• Other Study ID Numbers: 38RC20.165
• First Posted: December 24, 2020
• Last Update Posted: February 1, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations