![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00159172 |
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.
Condition | Intervention | Phase |
---|---|---|
Parkinson Disease |
Device: Motor cortex stimulation |
Phase I Phase II |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | May 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 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephane Palfi, MD, PhD | 33149812203 | stephane.palfi@hmn.aphp.fr |
France | |
Neurosurgical Department Henri Mondor Hospital | Recruiting |
Creteil, France, 94100 | |
Contact: Yves Kéravel, MD 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 | |
Sub-Investigator: Pierre Albaladejo, MD, PhD |
Principal Investigator: | Stephane Palfi, MD, PhD | Paris 12 University- APHP |
Study ID Numbers: | Parkostim |
Study First Received: | September 7, 2005 |
Last Updated: | March 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00159172 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Advanced parkinson disease Stimulation Motor Cortex |
Parkinson disease C10.574.812 Electric Stimulation Therapy E02.831.580.438 Neuronavigation E05.873.249 |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |