NCT02931097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 8, 2025

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

October 7, 2016

Last Update Submit

September 1, 2025

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDeep brain stimulationMesencephalic locomotor region

Outcome Measures

Primary Outcomes (1)

  • Change in the anticipatory postural adjustments between each deep brain stimulation condition

    3, 5, 7 months after surgery

Study Arms (3)

Pedunculopontine stimulation

ACTIVE COMPARATOR

Deep brain stimulation of the pedunculopontine area

Device: Deep brain stimulation

Pontomesencephalic stimulation

ACTIVE COMPARATOR

Deep brain stimulation of the pontomesencephalic area

Device: Deep brain stimulation

Sham stimulation

SHAM COMPARATOR

No deep brain stimulation

Device: Sham stimulation

Interventions

Deep brain stimulationDEVICE

Stimulating deep brain electrodes and pulse generator

Pedunculopontine stimulationPontomesencephalic stimulation
Sham stimulationDEVICE
Sham stimulation

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • dementia (Mattis Dementia Rating Scale \< 129, MDRS),
  • ongoing psychiatric disturbances,
  • surgical contraindications
  • significant brain lesions detected on MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 34744048BACKGROUND

  • 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.

    PMID: 35121249BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marie-Laure Welter, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 12, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2020

Last Updated

September 8, 2025

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)