Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
Researchers are trying to determine if tracking seizure occurrence, seizure probability,
 behavioral state, cognition, and mood can be achieved using an implantable brain sensing and
 stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient
 assistant device (PAD) with capability for patient interaction (patient data input). The
 system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation,
 and machine learning algorithms running on the RC+S and PAD that will be coupled with
 electrical brain stimulation (EBS) to prevent seizures and improve quality of life in
 patients with epilepsy.
This study will include patients with dominant temporal lobe epilepsy and bilateral temporal
 lobe epilepsy. The plan is to have 10 patients take part in this study at Mayo Clinic
 Rochester.
Inclusion Criteria

 -  Focal epilepsy, including seizures with and without impairment of consciousness, and
 secondarily generalized seizures:

 -  Disabling seizure counts >3 per month (Disabling seizures are those with
 significant negative impact on the patients life)

 -  Drug resistance to >2 appropriate seizure drugs with therapeutic serum
 concentrations

 -  Not a good candidate for resective surgery or at significant risk for verbal
 memory decline as determined by our institution's multidisciplinary Epilepsy
 Surgery Committee.

 -  For 3 months prior to enrollment, subject's anti-seizure medication dosages have
 been stable and subject has had at least 6 disabling (as defined in Inclusion
 Criteria 1) seizures per month, on average, with a seizure-free interval not to
 exceed 30 days. Seizures must be separated by a minimum of eight hours not to be
 considered part of a cluster. A cluster of seizures, for the purpose of this
 criterion, shall be considered a single seizure.

 -  With the exception of epilepsy, subject must be medically and neurologically stable.

 -  Mayo Clinic Epilepsy Surgery Committee approval for brain stimulation therapy obtained
 on clinical grounds and without reference to this protocol.

 -  Age 18 to 75

 -  Ability and willingness to provide informed consent and participate in the study
 protocol. Subject is able to interpret and to respond, in accordance with the study
 protocol, to the advisory indicators provided by the device.

 -  Subject has seizures that are distinct, stereotypical events that can be reliably
 counted by the patient or caregiver.

 -  Subject can reasonably be expected to maintain a seizure diary alone or with the
 assistance of a competent individual.

 -  Subject is able to complete regular office visits and telephone appointments in
 accordance with the study protocol requirements.

 -  A female subject must have a negative serum pregnancy test within two weeks prior to
 entering the study, and, if sexually active, must be using a reliable form of birth
 control, be surgically sterile, or be at least two years post-menopausal.

 -  Subject's seizure focus, based upon clinical semiology, intracranial
 electroencephalographic (iEEG) findings, and/or neuroimaging, shall demonstrate
 bilateral medial temporal lobe epilepsy or unilateral temporal lobe epilepsy of
 dominant temporal lobe origin.

 -  Subject has been informed of his or her eligibility for resective surgery as a
 potential alternative to the study, if such surgery is a reasonable option.

 -  Subject speaks and reads English.

 -  Subject has had a brain magnetic resonance imaging (MRI) epilepsy evaluation within
 the past two years.

 -  Subject has iEEG documentation of ictal events consistent with his or her predominant
 current seizure type.

 -  Subject's anatomy will permit implantation of the Medtronic Investigational RC+S
 generator within 20 mm of the skin surface.

 -  Subject can reasonably be expected to periodically check battery levels and recharge
 devices (Implanted neural stimulator (INS), Clinical Telemetry Module (CTM), and EPAD
 tablet) alone or with the assistance of a competent individual.

 Exclusion Criteria

 -  For 3 months prior to enrollment, subject's anti-seizure medication dosages have not
 been stable, or subject has had more than 25 disabling (as defined in Inclusion
 Criteria 1) seizures per month, on average, or there was a seizure-free interval
 longer than 30 days within the past 3 months. Clinical seizures must be separated by a
 minimum of eight hours to not be considered part of a cluster. Cluster seizures are
 considered a single seizure event.

 -  Subject has a contraindication to magnetic resonance imaging.

 -  Subject has a substance abuse history (alcohol, prescription, or illicit medications)
 within the preceding two years.

 -  Subject participated in another drug or device trial within the preceding 30 days.

 -  Subject has been hospitalized for a psychiatric condition within the preceding two
 years or has had a history of psychosis within the preceding two years (excluding
 post-ictal psychosis).

 -  Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac
 management product, or a medical device that interferes with the RC+S device. This
 includes, but is not limited to, direct brain neurostimulators, spinal cord
 stimulators, vagus nerve stimulators (VNS), and cochlear implants. Patients with a
 vagus nerve stimulator implanted but turned off through the duration of the study may
 be enrolled, provided their clinical status has been stable for at least one month
 with VNS turned off. Alternatively, patients with a VNS may have the previously
 disabled VNS removed at time of surgery to implant the Medtronic RC+S.

 -  Subject has been diagnosed with psychogenic or non-epileptic seizures.

 -  Subject has been diagnosed with primary generalized seizures.

 -  Subject has experienced unprovoked status epilepticus in the preceding year.

 -  Subject has had therapeutic surgery to treat epilepsy that may interfere with
 electrode placement.

 -  Subject is on anticoagulants and is unable to discontinue them peri-surgically, as
 required by the neurosurgeon or Investigator.

 -  Subject has significant platelet dysfunction from medical conditions or medications
 (including, particularly, aspirin or sodium valproate). If platelet dysfunction is
 suspected, subject can be enrolled only if a hematologist, the Investigator, and the
 neurosurgeon judge it to be advisable.

 -  Subject is ineligible for cranial surgery.

 -  Pregnancy