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NEUROPACE RESPONSIVE NEUROSTIMULATOR SYSTEM (RNS) PIVOTAL INVESTIGATION

The RNS Pivotal Investigation is a randomized, double-blind investigation being conducted at approximately 25 sites throughout the United States. The investigation is designed to assess the safety and effectiveness of responsive brain stimulation (delivered by the Neuropace RNS device) in reducing the frequency and severity of medically uncontrolled partial onset seizures in individuals 18 years of age or older with partial onset seizures that are not controlled despite trials of two or more antiepileptic medications.

The responsive neurostimulator (RNS) and leads are implanted in the head.  The RNS (a pacemaker-like device) has a small battery for power and a microprocessor that detects and records 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.

Study participation is expected to last for approximately 2-years. All patients in the trial will be implanted with the RNS device. During the double-blind portion of the trial, half of the patients will have responsive stimulation turned ON and half will have responsive stimulation turned OFF. Patients will not know whether stimulation is being delivered or not. After several months, when the double-blinded portion of the trial is completed, all patients 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/Exclusion Criteria

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

  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
  4. Between the ages of 18 and 70 years.
  5. One or 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 your or your doctor feel you might be a candidate for this investigational treatment, or to learn more about this trial, please contact:

Justine Cormier
Clinical Research Coordinator for the Epilepsy Service
Phone: 617.726.5904
Email: jecormier@partners.org
For more information from the sponsor, visit their website at:
http://www.neuropace.com/trials/overview.html

Cognitive effects of treatment of interictal discharges with levetiracetam

Many patients with epilepsy have subtle or transient cognitive deficits in the setting of otherwise normal intelligence.  It is thought that frequent interictal discharges may contribute to this phenomenon.  It is unknown, however, whether treatment of the discharges will improve cognitive performance. 

We are conducting a study to evaluate the effects of treatment of interictal discharges with levetiracetam, to assess whether levetiracetam does in fact reduce abnormal interictal activity, and whether this reduction correlates with improved cognitive task performance.  The study involves patients newly diagnosed with seizures, who will be placed on levetiracetam monotherapy and undergo EEG and cognitive testing pre- and post-treatment.  The study will include subjects with and without frequent interictal epileptiform discharges.  The trial duration is 11 weeks.

Subject must meet criteria which include:
●  18-55 years of age
●  Newly diagnosed focal epilepsy
●  The subject’s treating physician is planning to prescribe levetiracetam for seizure prevention
●  Untreated with antiepileptic medications at the time of enrollment

If you or your doctor feel that you might be a candidate for this study, or if you wish to obtain more information, please contact:
Beth Leeman, M.D.
Phone:  617-726-3311
E-mail:  baleeman@partners.org

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