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Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study)

NCT00821743 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-04-24

No results posted yet for this study

Summary

Disturbance of posture, gait and balance usually appear several years after Parkinson's disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug treatment, can generate a loss of autonomy and traumatic complications. Improvement of these axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been described for a small number of patients. The objectives of the present prospective monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life in five patients with severe PD. The use of detailed clinical rating scales and quantitative computer-based gait analysis will allow to identify the optimal stimulation parameters and relevant clinical efficacy parameters, mandatory for the design of further comparative large-scale studies.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Deep brain stimulation electrode

The DBS electrodes (model 3389, Medtronic) will be stereotactically implanted bilaterally in the PPN, according to the technique usually used for STN-DBS, and connected to the subcutaneously implanted stimulator (Kinetra, Medtronic).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Denys FONTAINE, PhD · Department of neurosurgery, CHU de Nice

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821743 on ClinicalTrials.gov