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OpenTrials
Completed

NCT Number: NCT02931097

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

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.

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Key information

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep brain stimulation

Device

Stimulating deep brain electrodes and pulse generator

Sham stimulation

Device

Primary outcomes

  1. Change in the anticipatory postural adjustments between each deep brain stimulation condition

    Time frame: 3, 5, 7 months after surgery

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: GAITPARK

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 12, 2016
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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