SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Summary
The purpose of this research is to study the safety and effectiveness of electrical stimulation to treat uncontrolled seizures in adults with epilepsy.
Description
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 prospective, randomized, double-blind 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 enrollment of 158 patients at 17 sites in the U.S. A minimum of 102 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 three-month 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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Epilepsy
Intervention
Intercept™ Epilepsy Control System, Intercept™ Epilepsy Control System
Status
Active, not recruiting
Source
MedtronicNeuro
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00101933
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vasomotor System
The neural systems which act on VASCULAR SMOOTH MUSCLE to control blood vessel diameter. The major neural control is through the sympathetic nervous system.
Myoclonic Epilepsy, Juvenile
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
Mephenytoin
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
Kallikrein-kinin System
A system of metabolic interactions by products produced in the distal nephron of the KIDNEY. These products include KALLIKREIN; KININS; KININASE I; KININASE II; and ENKEPHALINASE. This system participates in the control of renal functions. It interacts with the RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM to regulate BLOOD PRESSURE, generation of PROSTAGLANDINS, release of VASOPRESSINS, and WATER-ELECTROLYTE BALANCE.
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