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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02931097

Acronym

GAITPARK

Enrollment

Registered

2016-10-12

Start date

2016-10-31

Completion date

2020-10-31

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region

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.

Interventions

DEVICEDeep brain stimulation

Stimulating deep brain electrodes and pulse generator

DEVICESham stimulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 71 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026