Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
1 other identifier
interventional
10
1 country
1
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 with dopaminergic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 parkinson-disease
Started Sep 2005
Longer than P75 for phase_1 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMarch 6, 2007
September 1, 2005
September 7, 2005
March 5, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurosurgical Department Henri Mondor Hospital
Créteil, 94100, France
Related Publications (1)
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. doi: 10.1016/j.neuron.2004.11.023.
PMID: 15572109BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephane Palfi, MD, PhD
Paris 12 University- APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- ECT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
September 1, 2005
Study Completion
May 1, 2008
Last Updated
March 6, 2007
Record last verified: 2005-09