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


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Clinical Trial: Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease.

This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris September 2005

Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00159172

Purpose

The purpose of this study is to determine whether motor cortex stimulation, a middly invasive surgical procedure, is safe and effective in advanced stage of Parkinsonian patients who display side effects with dopaminergic treatment.
Condition Intervention Phase
Parkinson disease C10.574.812
Electric Stimulation Therapy E02.831.580.438
Neuronavigation E05.873.249
 Device: Motor cortex stimulation
Phase I
Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title: Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease.

Further Study Details: 
Primary Outcomes: Safety of the treatment and 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 Outcomes: Quality of life: PDQ39 scores; Anti-parkinsonian drug doses (equivalent L-Dopa); Results of motor activation study in PET scan; Results of the different neuropsychological tests; Video movement analysis
Expected Total Enrollment:  10

Study start: September 2005;  Expected completion: May 2009
Last follow-up: May 2008;  Data entry closure: December 2008

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 sophisticated technical environment, including stereotactic 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 can not 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 a continuous cortical stimulation. Such a cortical stimulation have 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 tolerance and efficacy of chronic stimulation of 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, increase movement velocities, and finally a better quality of life associated with reduction in dopaminergic medication and low per-operative morbidity risk

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years
  • Idiopathic Parkinson disease, for at least 5 years of evolution
  • Asymetric akineto-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted at the left side).
  • Functional impairment score in Off stage (no drug treatment) of 3-4 according to the Hoehn & Yahr scale (see appendix 1)
  • UPDRS III score > 40 in Off drug stage (see appendix X).
  • 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
  • MMS score  24 or Mattis score < 130 or 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00159172

Stephane Palfi, MD.,PhD      33149812203    stephane.palfi@hmn.aphp.fr

France
      Neurosurgical department Henri Mondor Hospital, Creteil,  94100,  France
Yves Kéravel, MD  33149812201 
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,  Sub-Investigator
Stephane Palfi, MD.,PhD,  Principal Investigator
Pierre Albaladejo, MD.,PhD,  Sub-Investigator

Study chairs or principal investigators

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

More Information

Publications

Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson''''s disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78.

Study ID Numbers:  Parkostim
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00159172
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13

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