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Trial # 1 Update August 14, 2007 (Reprinted With Permission)
The Department of Neurology at the University of Florida McKnight Brain Institue
UNIVERSITY OF FLORIDA
Department of Neurology Gainesville, FL
McKnight Brain Insitute
P.O. Box 100236
Gainesville, FL 32610-0236
Deborah T. Townsend, M.S. 352-273-5901
Pivotal Clinical Trail for Treatment of Epilepsy
Doctors at the University of Florida's Department of Neurology are enrolling participants in the Responsive Neurostimulator (RNS tm) System Pivotal Clinical Investigation, a multi-center clinical trial of a responsive brain neurostimulator for the treatment of epilepsy. The RNS is an implantable device that is designed to suppress seizures in patients with epilepsy before any symptoms appear, much like implantable cardiac pacemakers are intended to detect abnormal heart rhythms and then deliver electrical stimulation to correct them.
The RNS is surgically implanted under the scalp and connected to one or two leads (insulated wires with 4 small electrodes at the end). These leads are implanted within the patient's brain and/or placed on the brain surface, in the area of the presumed seizure origin The RNS continuously monitors the patient's brain waves. When seizure activity is detected, the device delivers brief and mild electrical stimulation through the leads in an attempt to suppress seizures.
After the RNS is implanted, patients visit their neurologist for follow-up appointments/ The neurologist uses a modified laptop computer to program the device to recognize the patient's seizure activity. When seizure activity is detected, the RNS delivers stimulation that is intended to stop the seizure from occurring.
Previous clinical testing of responsive stimulation to control epilepsy was conducted in 65 patients implanted with the device in the RNS System Feasibility Clinical Investigation. This study was designed to evaluate safety and obtain initial evidence of efficacy of the RNS system in treating epilepsy. As a result of this study, FDA has granted approval to conduct the RNS System Pivotal Clinical Investigation.
Persons eligible to participate in the RNS System Pivotal Clinical Investigation are adult (18-70 years of age) who have an average of 3 or more partial (focal) onset seizures that have not been controlled on at least 2 antiseizure medications. Before enrolling in the trail, patients will have undergone various standard tests that may include EEG (electroencephalography) and MRI (magnetic resonance imaging) to localize their seizure onset area(s).
Once enrolled, participants undergo a baseline evaluation for a minimum of three months, During this period, participants keep a seizure diary and see a neurologist on a regular schedule. Participants who meet the seizure frequency criteria of an average of 3 or more seizures per month for three consecutive months are eligible to receive the implanted neurostimulator. After the device is implanted, participants are followed for two years. Seizure type and frequency, and physical and emotional health are assessed regularly.
Epilepsy is a common neurological condition affecting about 2.5 million Americans of all ages. As many as 50% of persons with epilepsy continue to have seizures to have antiseizure medication side effects despite best medical efforts to control their seizures. some patients are candidates for epilepsy surgery to remove the seizure focus. However, patients with some types of epilepsy are unlikely to respond to surgery or may be at high risk for surgery related neurological complications. Brain devices to treat epilepsy may offer hope to those persons with epilepsy who are not adequately treated by antiseizure medication and are not candidates for safe and effective surgery.
CLICK HER FOR A LINK TO MORE INFORMATION
or call 1-800-904-7907
For more information about the RNS System Pivotal Clinical Investigation
at the University of Florida McKnight Brain Institute
contact Deborah Townsend at 352-273-5901.
Trial # 2 Update August 14, 2007 (Reprinted With Permission)
Do You
or Someone
You Know
Have
Epilepsy?
Epilepsy is a common disorder in adults affecting approximately 2 million
people in the United States of America.
Medical researchers are enrolling participants in a clinical study for the
treatment of Epilepsy.
Participants will receive study medication or placebo and all study-related
medical care at no cost and may be compensated for time and travel.
Patients completing this trial also will be eligible to enroll in a 4-month extension
study.
You may qualify if :
♦ You are 18 to 69 years of age
♦ You have been diagnosed with complex partial seizures
♦ You usually experience 3 or more seizures per month
♦ You take 1 to 3 physician prescribed drugs for your seizures
For more information go to www.clinicaltrials.gov or call 1 877 315 0566.
You may also call:
The University of Florida McKnight Brain Institute
contact Deborah Townsend at 352-273-5901.