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

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ClinicalTrials.gov Identifier: NCT02931097
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep brain stimulation Device: Sham stimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pedunculopontine stimulation
Deep brain stimulation of the pedunculopontine area
Device: Deep brain stimulation
Stimulating deep brain electrodes and pulse generator

Active Comparator: Pontomesencephalic stimulation
Deep brain stimulation of the pontomesencephalic area
Device: Deep brain stimulation
Stimulating deep brain electrodes and pulse generator

Sham Comparator: Sham stimulation
No deep brain stimulation
Device: Sham stimulation



Primary Outcome Measures :
  1. Change in the anticipatory postural adjustments between each deep brain stimulation condition [ Time Frame: 3, 5, 7 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931097


Contacts
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Contact: Gabriellle Derocle gabrielle.derocle@inserm.fr

Locations
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France
Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere Recruiting
Paris, France, 75013
Contact: Sylvie Coudoin, Nurse    +33142165772    sylvie.coudoin@aphp.fr   
Principal Investigator: Marie-Laure Welter, MD, PhD         
Sub-Investigator: Carine Karachi, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Marie-Laure Welter, MD, PhD APHP

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02931097     History of Changes
Other Study ID Numbers: C15-46
2016-A00792-49 ( Registry Identifier: ID RCB )
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Parkinson's disease
Deep brain stimulation
Mesencephalic locomotor region

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases