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Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease

NCT04682678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Gait Disorders, Neurologic

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Elena MORO · CHUGA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2023-07-11
Completion
2023-07-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682678 on ClinicalTrials.gov