STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy

NCT00228371 | Terminated Phase 2 DMC

• 1 other identifier: DCIC 03 23
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Epilepsy; Drug Resistant

Keywords

Epilepsy; deep brain stimulation; Subthalamic nucleus; Drug resistant epilepsy

Outcome Measures

Primary Outcomes (1)

• - Daily seizure frequency at each phase

  at each phase

Secondary Outcomes (3)

• The number of days without seizure during each phase

  at each phase

• Quality of life : SEALS, QOLIE-31 and NHP scales

  at each phase

• 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

Study Arms (2)

1

OTHER

The stimulator is switch ON during the first phase of the cross-over and switch OFF during the second phase

Device: Neurostimulation

2

OTHER

The stimulator is switch OFF during the first phase of the cross-over and switch ON during the second phase

Device: Neurostimulation

Interventions

Neurostimulation DEVICE

High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA

Also known as: Neurostimulation of subthalamic nucleus

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Ministry of Health, France: collaborator

Study Sites (3)

University Hospital of Grenoble

Grenoble, Isere, 38043, France

Location

University Hospital of Rennes

Rennes, 35000, France

Location

University Hospital of Strasbourg

Strasbourg, 67091, France

Location

Related Publications (9)

• Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.

  PMID: 1695401 BACKGROUND

• 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. doi: 10.1002/1531-8249(199908)46:23.0.co;2-z.

  PMID: 10443887 BACKGROUND

• 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. doi: 10.1007/pl00007825.

  PMID: 11697687 BACKGROUND

• Benabid AL, Minotti L, Koudsie 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. doi: 10.1097/00006123-200206000-00037.

  PMID: 12015863 BACKGROUND

• Chabardes 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.

  PMID: 12495878 BACKGROUND

• 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. doi: 10.1159/000099878.

  PMID: 9711758 BACKGROUND

• Cooper IS, Amin I, Gilman S. The effect of chronic cerebellar stimulation upon epilepsy in man. Trans Am Neurol Assoc. 1973;98:192-6. No abstract available.

  PMID: 4206369 BACKGROUND

• DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.

  PMID: 1695404 BACKGROUND

• 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.

  PMID: 14684352 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stephan CHABARDES, Dr

  University Hospital of Grenoble, Neuro surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

FR (3)