Status:
UNKNOWN
Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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 stimul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00159172
Start Date
September 1 2005
End Date
May 1 2008
Last Update
March 6 2007
Active Locations (1)
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1
Neurosurgical Department Henri Mondor Hospital
Créteil, France, 94100