DBS of the MLR for Gait and Balance Disorders in PD Patients (GAITPARK)

September 1, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study

Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age below 71 years
  • severe form of Parkinson's Disease with disease duration > 5 years
  • presence of gait and/or balance disorders unresponsive to levodopa treatment,
  • > 40% decrease in others motor symptoms with levodopa treatment
  • health insurance
  • give signed informed written consent

Exclusion Criteria:

  • dementia (Mattis Dementia Rating Scale < 129, MDRS),
  • ongoing psychiatric disturbances,
  • surgical contraindications
  • significant brain lesions detected on MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pedunculopontine stimulation
Deep brain stimulation of the pedunculopontine area
Device: Deep brain stimulation
Stimulating deep brain electrodes and pulse generator
Active Comparator: Pontomesencephalic stimulation
Deep brain stimulation of the pontomesencephalic area
Device: Deep brain stimulation
Stimulating deep brain electrodes and pulse generator
Sham Comparator: Sham stimulation
No deep brain stimulation
Device: Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Time Frame: 3, 5, 7 months after surgery
3, 5, 7 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Marie-Laure Welter, MD, PhD, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimated)

October 12, 2016

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C15-46
  • 2016-A00792-49 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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