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Clinical Trials/NCT02931097
NCT02931097
Completed
Not Applicable

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

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country6 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
6
Locations
1
Primary Endpoint
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
October 1, 2020
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 3, 5, 7 months after surgery

Study Sites (1)

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