Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

NCT03946618 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 18-005483UH2NS095495-03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (5)

• Adverse events (AE) experienced with the RC+S system

  Number of AEs reported

  Through 15 months

• 24/7 continuous iEEG monitoring

  Number of RC+S systems that generates continues 24/7 EEG without interruption

  Through 15 months

• Change in mood

  Measured using daily mood and anxiety trackers questionnaire, where 1 is not at all and 7 is extremely

  Baseline, biweekly for up to 15 months

• Change in anxiety

  Measured using anxiety Generalized Anxiety Disorder 7-item (GAD-7) scale, where 0 is not at all sure and 3 is nearly every day

  Baseline, biweekly for up to 15 months

• Tracking cognition

  Measured using free recall task

  Baseline, biweekly for up to 15 months

Study Arms (1)

Epilepsy

EXPERIMENTAL

Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy

Device: Medtronic Summit System, Olympus

Interventions

Medtronic Summit System, Olympus DEVICE

Electrical brain stimulation with an implantable pulse generator

Epilepsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medtronic: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Balzekas I, Trzasko J, Yu G, Richner TJ, Mivalt F, Sladky V, Gregg NM, Van Gompel J, Miller K, Croarkin PE, Kremen V, Worrell GA. Method for cycle detection in sparse, irregularly sampled, long-term neuro-behavioral timeseries: Basis pursuit denoising with polynomial detrending of long-term, inter-ictal epileptiform activity. PLoS Comput Biol. 2024 Apr 25;20(4):e1011152. doi: 10.1371/journal.pcbi.1011152. eCollection 2024 Apr.

  PMID: 38662736 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gregory A Worrell

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Epilepsy

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 10, 2019
• Study Start: January 18, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)