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Therapeutic Areas: Neurology
Disease Category: Epilepsy
Trial Information
RNS™ System Pivotal Clinical Investigation
NeuroPace, Inc is sponsoring an investigational device study of
the Responsive Neurostimulator (RNS™) system, the company's
responsive brain stimulation therapy for refractory epilepsy. The
RNS Pivotal Clinical Investigation is designed to assess the safety
and to demonstrate that the Responsive Neurostimulator (RNS™)
system is effective as an add-on (adjunctive) therapy in reducing
the frequency of seizures in individuals 18 years of age or older
with partial onset seizures that are refractory (resistant or hard
to treat) to two or more anti-epileptic medications. Candidates
will continue to receive their epilepsy medications while
participating in the trial.
The RNS Pivotal Clinical Investigation is a randomized,
double-blind, sham stimulation controlled investigation being
conducted at approximately 28 sites throughout the United States.
The investigation is designed to assess the safety and
effectiveness of responsive brain stimulation (delivered by the RNS
device) in reducing the frequency of medically uncontrolled partial
onset seizures (those that start from one area of the brain).
The responsive neurostimulator and leads are implanted in the
head. The RNS (a pacemaker-like device) has a small battery for
power and a microprocessor that detects (senses) and stores
electrical activity from the brain. When the RNS detects a seizure,
it responds by sending electrical stimulation through leads (tiny
wires with electrodes) to a small part of the patient's brain
to stop the seizure. This type of treatment is called responsive
stimulation, but it is not yet known if it will work for the
treatment of epilepsy. 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 participation is expected to last approximately two (2) to
three (3) years. All participants in the trial will be implanted
with the RNS device. During the double-blind portion of the trial,
half of the participants will have responsive stimulation turned ON
and half will have responsive stimulation turned OFF. Participants
will not know whether stimulation is being delivered or not. Five
months after the RNS has been implanted, when the double-blinded
portion of the trial is completed, all participants will be able to
have stimulation turned ON. Seizure frequency and severity, as well
as physical and emotional health will be followed throughout the
study.
Patient Inclusion Criteria:
1. Disabling motor simple partial
seizures, complex partial seizures, and/or secondarily generalized
seizures. Disabling refers to seizures that are severe enough to
cause injuries, or significantly impair functional ability in areas
such as employment, psychological or social wellbeing, or in
mobility.
2. Failed treatment with a minimum of two anti-seizure
medications.
3. An average of three or more seizures every 28 days for three
consecutive 28-day periods.
4. Between the ages of 18 and 70 years.
5. No more than two epileptogenic brain regions.
Note: Patients with vagus 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 (excluding leads) prior to or at the time of
the RNS implant.
If you meet these criteria and would like more information, you
or your physician can contact one of the participating clinical
trial sites.
Deborah Townsend
University of Florida
Located in:
Gainesville, FL
Phone: 352-273-5901
EMail: deborah.townsend@neurology.ufl.edu
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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