The purpose of this research is to study the safety and effectiveness of electrical stimulation to treat uncontrolled seizures in adults with epilepsy.

Condition	Treatment or Intervention	Phase
Epilepsy	Device: Intercept™ Epilepsy Control System	Phase III

Further Study Details: 

Expected Total Enrollment:  124

Medtronic, Inc. is sponsoring an investigational study of the Intercept™ Epilepsy Control System, the company's direct brain stimulation therapy for patients with refractory epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of these patients is refractory, or continues to experience seizures despite a wide range of treatment options.

The trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy. It includes approximately 124 patients in a prospective, randomized, double-blind study at approximately 15 sites in the U.S. and Canada. All patients will be implanted and monitored for 13 months following implant, with long-term follow-up until the device is approved or the study is stopped.

Patients in the active group, who will receive neurostimulation, will be monitored for a reduction in seizure rates compared to the control group, who will not receive neurostimulation during the double-blind phase. After the double-blind phase, all patients will receive neurostimulation.

Candidates for the trial are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. They will have had an average of six or more seizures per month. Candidates will continue to receive their epilepsy medications while participating in the trial.

Direct brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Below is a list of some of the criteria used in determining whether or not a patient is an appropriate candidate.

Inclusion Criteria:

• Partial-onset seizures with or without secondary generalization.
• Average of 6 or more partial-onset seizures per month.
• Between 18 and 65 years of age.
• Refractory to antiepileptic drugs (AEDs).

Note: Patients with vagal nerve stimulators may be eligible for this clinical trial if the device has been turned off for a specified period of time and the patient agrees to have the generator explanted prior to or at the time of the Intercept™ Epilepsy Control System implant.

If you meet these criteria, and would like more information, you or your physician can contact one of the clinical trial sites.

California
      University of California San Francisco, San Francisco,  California,  94143,  United States; Recruiting
      Stanford University School of Medicine, Stanford,  California,  94305,  United States; Recruiting
      VA Greater Los Angeles Healthcare System/UCLA, Los Angeles,  California,  90073,  United States; Recruiting
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Indiana University Medical Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
New York
      Weill Cornell Medical Center, Comprehensive Epilepsy Center, New York,  New York,  10021,  United States; Recruiting
Oklahoma
      Oklahoma University Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study ID Numbers:  1604
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  January 18, 2005
ClinicalTrials.gov Identifier:  NCT00101933
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08