- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946618
Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
June 29, 2023 updated by: Gregory Worrell, Mayo Clinic
Human Safety and Feasibility Study of 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karla Crockett
- Phone Number: 507-538-9140
- Email: crockett.karla@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epilepsy
Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy
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Electrical brain stimulation with an implantable pulse generator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AE) experienced with the RC+S system
Time Frame: Through 15 months
|
Number of AEs reported
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Through 15 months
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24/7 continuous iEEG monitoring
Time Frame: Through 15 months
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Number of RC+S systems that generates continues 24/7 EEG without interruption
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Through 15 months
|
Change in mood
Time Frame: Baseline, biweekly for up to 15 months
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Measured using daily mood and anxiety trackers questionnaire, where 1 is not at all and 7 is extremely
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Baseline, biweekly for up to 15 months
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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
|
Baseline, biweekly for up to 15 months
|
Tracking cognition
Time Frame: Baseline, biweekly for up to 15 months
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Measured using free recall task
|
Baseline, biweekly for up to 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory A Worrell, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2019
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
April 19, 2019
First Submitted That Met QC Criteria
May 9, 2019
First Posted (Actual)
May 10, 2019
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-005483
- UH2NS095495-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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