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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Deep brain stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region