Epilepsy Clinical Trial
Official title:
Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.
The aim of this study is to evaluate the effectiveness and the safety of deep brain
stimulation in drug resistant epilepsy.
This is a double blind, controlled and randomized clinical trial with two cross-over groups
and four phases.
Phase 1 : base line, open phase consisting of follow-up of patients with their standard
treatment.
Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the
stimulator switch OFF.
Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF
depending on randomization allocation, followed by 3 months with the stimulator switch on
the opposite position. The placebo consisting of turn OFF the stimulator.
Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Epilepsy resistant to antiepileptic drug and dopaminergic D2 agonist. - No curative exeresis surgery possible - Metabolism deficiency of DOPA above 1 DS, evaluated by Positron Emission Tomography (PET) using fluorodopa - Age ranging from 18 to 50 - capacity to consent - Affiliation to the French Social Security Exclusion Criteria: - pregnant woman or nursing mother - change of antiepileptic, 30 days before base line - convulsive "etat de mal" that requires an hospitalisation, 30 days before base line |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Grenoble | Grenoble | Isere |
France | University Hospital of Rennes | Rennes | |
France | University Hospital of Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Ministry of Health, France |
France,
Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. Review. — View Citation
Ardouin C, Pillon B, Peiffer E, Bejjani P, Limousin P, Damier P, Arnulf I, Benabid AL, Agid Y, Pollak P. Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients. Ann Neurol. 1999 Aug;46(2):217-23. — View Citation
Benabid AL, Koudsie A, Benazzouz A, Vercueil L, Fraix V, Chabardes S, Lebas JF, Pollak P. Deep brain stimulation of the corpus luysi (subthalamic nucleus) and other targets in Parkinson's disease. Extension to new indications such as dystonia and epilepsy. J Neurol. 2001 Sep;248 Suppl 3:III37-47. Review. — View Citation
Benabid AL, Minotti L, Koudsié A, de Saint Martin A, Hirsch E. Antiepileptic effect of high-frequency stimulation of the subthalamic nucleus (corpus luysi) in a case of medically intractable epilepsy caused by focal dysplasia: a 30-month follow-up: technical case report. Neurosurgery. 2002 Jun;50(6):1385-91; discussion 1391-2. — View Citation
Chabardès S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93. — View Citation
Chkhenkeli SA, Chkhenkeli IS. Effects of therapeutic stimulation of nucleus caudatus on epileptic electrical activity of brain in patients with intractable epilepsy. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):221-4. — View Citation
Cooper IS, Amin I, Gilman S. The effect of chronic cerebellar stimulation upon epilepsy in man. Trans Am Neurol Assoc. 1973;98:192-6. — View Citation
DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. Review. — View Citation
Dematteis M, Kahane P, Vercueil L, Depaulis A. MRI evidence for the involvement of basal ganglia in epileptic seizures: an hypothesis. Epileptic Disord. 2003 Sep;5(3):161-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Daily seizure frequency at each phase | at each phase | Yes | |
Secondary | The number of days without seizure during each phase | at each phase | Yes | |
Secondary | Quality of life : SEALS, QOLIE-31 and NHP scales | at each phase | Yes | |
Secondary | Neuropsychological test : WAIS, GROBER and Busckhe, Wisconsin Card Sorting Test, TRAIL test, LURIA test, Beck Depression Inventory, verbal flow test, empathy test | at each phase | Yes |
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