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
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.
Investigators
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