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| Sponsored by: |
NeuroPace |
|---|---|
| Information provided by: | NeuroPace |
| ClinicalTrials.gov Identifier: | NCT00079781 |
Purpose
The purpose of the Responsive Neurostimulator (RNS) system feasibility clinical investigation is to demonstrate safety, and to provide evidence of efficacy of the NeuroPace RNS system in reducing the number of seizures in patients having medically refractory epilepsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Device: Responsive Neurostimulator |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Responsive Neurostimulator (RNS) System Feasibility Clinical Investigation |
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2004 |
The clinical investigation has two separate protocols conducted by two different physicians: the Assessment Protocol and the Treatment Protocol.
The physician conducting the Assessment Protocol monitors seizure type, seizure frequency, and seizure severity for each subject. He or she also assesses the subject’s epilepsy-related physical and emotional health at predetermined intervals before and after the subject has been implanted with an RNS system.
After the subject is implanted with an RNS system, the physician conducting the Treatment Protocol manages the RNS system by monitoring and adjusting parameters (when necessary) for the responsive neurostimulation therapy. The physician conducting the Treatment Protocol has the important responsibility of not disclosing to the subject the therapy status (ON or OFF) during the Evaluation Period.
Three distinct time periods define the subject’s participation: Pre-implant, Evaluation, and Follow-up.
The Pre-implant Period begins when an eligible subject enrolls in the clinical investigation. Prior to surgery for implantation of the RNS system, subjects will undergo a neuropsychological evaluation.
The Evaluation Period begins once the subject is implanted with the RNS system. The subject is randomized to therapy ON or OFF for the 4 month duration of the Evaluation Period.
During the Evaluation Period, the physician conducting the Assessment Protocol assesses the subject’s epilepsy-related health at predetermined intervals.
The physician conducting the Treatment Protocol uses the implanted RNS system to achieve the best seizure control possible in those subjects randomized to therapy ON. The physician conducting the Assessment Protocol and the subject are blinded to the therapy status during the Evaluation Period.
In the course of the Evaluation Period, any changes in the type of antiseizure medication(s), discontinuation of antiseizure medication(s), or additions of new antiseizure medication(s) are discouraged. This also applies to any medication that has reported antiseizure properties even when prescribed for another indication. Adjustment to the antiseizure medication(s) dose to in order to maintain target blood serum levels or to avoid toxicity is acceptable. Acute, intermittent use of benzodiazepines is also acceptable.
The Follow-up Period is scheduled to begin at four months post-implant of the RNS system, however it will not commence until the appropriate data has been submitted to allow the therapy blinding status to be disclosed.
During the Follow-up Period, therapy may be programmed ON or OFF and medications may be adjusted to provide the most effective care for the subject. The physician conducting the Treatment Protocol uses the implanted RNS system to achieve the best seizure control possible.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: 1 month = 28 days
Exclusion Criteria:
Note: Subjects who have had epilepsy surgery (resective, corpus callosotomy, or ablation) greater than one year ago are still eligible.
Contacts and Locations| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
More Information
| Study ID Numbers: | 1006778 |
| Study First Received: | March 12, 2004 |
| Last Updated: | December 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00079781 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy, Neurostimulator, Electrical Stimulation |
|
Epilepsy Central Nervous System Diseases Brain Diseases |
|
Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |