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

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

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Deep brain stimulation; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02931097

C15-46

2016-A00792-49 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 3 patient groups

Pedunculopontine stimulation

Active Comparator group

Description:

Deep brain stimulation of the pedunculopontine area

Treatment:

Device: Deep brain stimulation

Pontomesencephalic stimulation

Active Comparator group

Description:

Deep brain stimulation of the pontomesencephalic area

Treatment:

Device: Deep brain stimulation

Sham stimulation

Sham Comparator group

Description:

No deep brain stimulation

Treatment:

Device: Sham stimulation