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

Parkinson's Disease Clinical Trial

— GAITPARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931097
• Other study ID #: C15-46
• Secondary ID: 2016-A00792-49
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: January 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep brain stimulation
Stimulating deep brain electrodes and pulse generator
• Sham stimulation

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the anticipatory postural adjustments between each deep brain stimulation condition		3, 5, 7 months after surgery