DBS of the MLR for Gait and Balance Disorders in PD Patients (GAITPARK)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Deep brain stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region
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.
Sites / Locations
- Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Pedunculopontine stimulation
Pontomesencephalic stimulation
Sham stimulation
Arm Description
Deep brain stimulation of the pedunculopontine area
Deep brain stimulation of the pontomesencephalic area
No deep brain stimulation
Outcomes
Primary Outcome Measures
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Secondary Outcome Measures
Full Information
NCT ID
NCT02931097
First Posted
October 7, 2016
Last Updated
January 10, 2022
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02931097
Brief Title
DBS of the MLR for Gait and Balance Disorders in PD Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pedunculopontine stimulation
Arm Type
Active Comparator
Arm Description
Deep brain stimulation of the pedunculopontine area
Arm Title
Pontomesencephalic stimulation
Arm Type
Active Comparator
Arm Description
Deep brain stimulation of the pontomesencephalic area
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
No deep brain stimulation
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
Stimulating deep brain electrodes and pulse generator
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Primary Outcome Measure Information:
Title
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Time Frame
3, 5, 7 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DBS of the MLR for Gait and Balance Disorders in PD Patients
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