Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease
Condition: Parkinson Disease; Gait Disorders, Neurologic
MeSH terms: Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

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.
    

Intervention name(s): Implantation of electrodes for Spinal cord stimulation
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment