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Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

  • Clinicaltrials.gov identifier

    NCT03946618

  • Recruitment Status

    Recruiting

  • First Posted

    May 10, 2019

  • Last update posted

    January 6, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Epilepsy
  • Intervention/Treatment: Device: Medtronic Summit System, Olympus
  • Phase: Phase 1

Detailed Description

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Epilepsy
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Human Safety and Feasibility Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: December 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Epilepsy
Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy
Device: Medtronic Summit System, Olympus
Electrical brain stimulation with an implantable pulse generator

Outcome Measures

  • Primary Outcome Measures: 1. Adverse events (AE) experienced with the RC+S system [ Time Frame: Through 15 months ]
    Number of AEs reported
  • 2. 24/7 continuous iEEG monitoring [ Time Frame: Through 15 months ]
    Number of RC+S systems that generates continues 24/7 EEG without interruption
  • 3. Change in mood [ Time Frame: Baseline, biweekly for up to 15 months ]
    Measured using daily mood and anxiety trackers questionnaire, where 1 is not at all and 7 is extremely
  • 4. Change in anxiety [ Time Frame: Baseline, biweekly for up to 15 months ]
    Measured using anxiety Generalized Anxiety Disorder 7-item (GAD-7) scale, where 0 is not at all sure and 3 is nearly every day
  • 5. Tracking cognition [ Time Frame: Baseline, biweekly for up to 15 months ]
    Measured using free recall task

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Karla Crockett 507-538-9140 crockett.karla@mayo.edu

Locations

United States, Minnesota
Mayo Clinic in Rochester
Rochester

Sponsors and Collaborators

Mayo Clinic

National Institute of Neurological Disorders and Stroke (NINDS)

Medtronic

Investigators

Principal Investigator: Gregory A Worrell Mayo Clinic

More Information

  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03946618 History of Changes
  • Other Study ID Numbers: 18-005483, UH2NS095495-03
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: January 6, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Epilepsies, Partial Epilepsy