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

NCT ID: NCT02931097

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-10-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Pedunculopontine stimulation

Deep brain stimulation of the pedunculopontine area

Group Type: ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type: DEVICE

Stimulating deep brain electrodes and pulse generator

Pontomesencephalic stimulation

Deep brain stimulation of the pontomesencephalic area

Group Type: ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type: DEVICE

Stimulating deep brain electrodes and pulse generator

Sham stimulation

No deep brain stimulation

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

Interventions

Deep brain stimulation

Stimulating deep brain electrodes and pulse generator

Intervention Type: DEVICE

Sham stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Laure Welter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere

Paris, , France

Countries

France

References

Bourilhon J, Olivier C, You H, Collomb-Clerc A, Grabli D, Belaid H, Mullie Y, Francois C, Czernecki V, Lau B, Perez-Garcia F, Bardinet E, Fernandez-Vidal S, Karachi C, Welter ML. Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation for Severe Gait and Balance Disorders in Parkinson's Disease: Interim Results from a Randomized Double-Blind Clinical Trial. J Parkinsons Dis. 2022;12(2):639-653. doi: 10.3233/JPD-212793.

Reference Type: BACKGROUND

PMID: 34744048 (View on PubMed)

Bourilhon J, Mullie Y, Olivier C, Cherif S, Belaid H, Grabli D, Czernecki V, Karachi C, Welter ML. Stimulation of the pedunculopontine and cuneiform nuclei for freezing of gait and falls in Parkinson disease: Cross-over single-blinded study and long-term follow-up. Parkinsonism Relat Disord. 2022 Mar;96:13-17. doi: 10.1016/j.parkreldis.2022.01.010. Epub 2022 Jan 22.

Reference Type: BACKGROUND

PMID: 35121249 (View on PubMed)

Other Identifiers

2016-A00792-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

C15-46

Identifier Type: -

Identifier Source: org_study_id