Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease

March 5, 2007 updated by: Assistance Publique - Hôpitaux de Paris

Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease

The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Advanced stage of Parkinson disease (PD) is a difficult condition to treat, especially after several years of dopaminergic drugs. Recent development of neurosurgical techniques using deep brain stimulation leads has shown good behavioral results in these advanced PD patients. However, the placement of a stimulation lead in the subthalamic nucleus is a complex, invasive, and long surgical procedure. Such intervention requires a sophisticated technical environment, including a stereotactic magnetic resonance imaging (MRI) exam, associated with per-operative electrophysiological exploration of deep brain structures. This surgical treatment can therefore be indicated only for a few selected patients, and cannot be offered to a large proportion of patients among the potential candidates (estimation of 5000 patients in France). Thus, there is a need to develop therapeutic alternatives that would be technically and practically more convenient, less invasive, and that could be offered to a larger number of patients. Several clinical studies, including one led by our group, have already demonstrated that transcranial magnetic cortical stimulation could improve bradykinesia and shorten motor reaction time in patients with Parkinson disease. The clinical benefit was however moderate, and transient, probably because the stimulating sessions were too short in duration.

A prolonged effect could be obtained with continuous cortical stimulation. Such cortical stimulation has already been developed with good clinical tolerance in our hospital since 1991 for chronic neuropathic pain syndromes. In a non-human primate model of late stage Parkinson disease, we have recently demonstrated that prolonged primary motor cortex stimulation significantly improved both akinesia and bradykinesia.

The primary objective of this pilot study will be to evaluate the tolerance and efficacy of chronic stimulation of the primary motor cortex in 10 patients suffering from advanced stage Parkinson disease, despite the optimisation of dopaminergic treatment. The expected benefit for the patient will be gait improvement, increased movement velocities, and finally a better quality of life associated with reduction in dopaminergic medication and low per-operative morbidity risk.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94100
        • Recruiting
        • Neurosurgical Department Henri Mondor Hospital
        • Contact:
          • Yves Kéravel, MD
          • Phone Number: 33149812201
        • Sub-Investigator:
          • Philippe Remy, MD, PhD
        • Sub-Investigator:
          • Jean Marc Gurruchaga, MD
        • Sub-Investigator:
          • Jean Paul N'Guyen, MD
        • Sub-Investigator:
          • Jean Pascal Lefaucheur, MD, PhD
        • Sub-Investigator:
          • Pierre Brugière, MD
        • Sub-Investigator:
          • Anne Catherine Bachoud-Levy, MD, PhD
        • Sub-Investigator:
          • Yves Kéravel, MD
        • Sub-Investigator:
          • Patrick Maison, MD
        • Sub-Investigator:
          • Marc Peschanski, PhD
        • Sub-Investigator:
          • Gilles Fenelon, MD
        • Principal Investigator:
          • Stephane Palfi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 70 years
  • Idiopathic Parkinson disease, for at least 5 years of evolution
  • Asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
  • Functional impairment score in off stage (no drug treatment) of 3-4 according to the Hoehn and Yahr scale
  • UPDRS III score > 40 in off-drug stage.
  • UPDRS III score with L-dopa treatment improved by at least 50% compared to UPDRS III score in off-drug stage

Exclusion Criteria:

  • Age superior to 70 years
  • Adult patients under guardianship
  • Previous neurosurgical operation(s)
  • Previous partial or generalised seizures
  • Mini Mental Status (MMS) score  24 or Mattis score < 130 or Montgomery-Asberg Depression Rating Scale (MADRS) depression score > 20.
  • Presence of signal abnormalities on T1- and T2- MRI sequences
  • Abnormalities in general exam or biological constants (hemogram, ionogram, hepatic or kidney dysfunction) with a higher surgical risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety of the treatment and Unified Parkinson Disease Rating Scale (UPDRS) III 1 month following constant stimulation with and without motor cortex stimulation when the patient has no anti-parkinsonian drug for 12 hours

Secondary Outcome Measures

Outcome Measure
Quality of life: Parkinson's Disease Questionnaire 39 (PDQ39) scores
Anti-parkinsonian drug doses (equivalent L-dopa)
Results of motor activation study in positron emission tomography (PET) scan
Results of the different neuropsychological tests
Video movement analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Stephane Palfi, MD, PhD, Paris 12 University- APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

May 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 6, 2007

Last Update Submitted That Met QC Criteria

March 5, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parkostim

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe