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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Deep brain stimulation; Device: Sham stimulation

• Registration Number: NCT02931097
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-12
• Primary Completion: 2019-10
• Study Completion: 2020-10
• Status Verified: 2021-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pontomesencephalic stimulation	Deep brain stimulation	Deep brain stimulation of the pontomesencephalic area
Pedunculopontine stimulation	Deep brain stimulation	Deep brain stimulation of the pedunculopontine area
Sham stimulation	Sham stimulation	No deep brain stimulation

Primary Outcome Measures

Name	Time	Method
Change in the anticipatory postural adjustments between each deep brain stimulation condition	3, 5, 7 months after surgery

Trial Locations

Locations (1)

Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere; 🇫🇷 Paris, France