EpilepsyNCT03946618
Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
A study testing Medtronic Summit System, Olympus in people with Epilepsy, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Medtronic Summit System, Olympus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Medtronic Summit System, Olympus
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Summit System, OlympusDevice
Electrical brain stimulation with an implantable pulse generator
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Experimental | Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy Receives: Device: Medtronic Summit System, Olympus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE) experienced with the RC+S system
Number of AEs reported
Measured: Through 15 months
24/7 continuous iEEG monitoring
Number of RC+S systems that generates continues 24/7 EEG without interruption
Measured: Through 15 months
Change in mood
Measured using daily mood and anxiety trackers questionnaire, where 1 is not at all and 7 is extremely
Measured: 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
Measured: Baseline, biweekly for up to 15 months
Tracking cognition
Measured using free recall task
Measured: Baseline, biweekly for up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start18 Jan 2019
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Epilepsy
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
- Responsible party
- Principal investigator, Gregory Worrell, Mayo Clinic
- Investigators
- Gregory A Worrell, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946618
- Sponsor's protocol ID
- 18-005483
- Other IDs
- UH2NS095495-03
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38662736
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Safety and Feasibility Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
- ClinicalTrials.gov ID
- NCT03946618
- Acronym / sponsor ID
- 18-005483
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Epilepsy
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Experimental | Device: Medtronic Summit System, OlympusPatients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Focal epilepsy, including seizures with and without impairment of consciousness, and secondarily generalized seizures:
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Summit System, OlympusElectrical brain stimulation with an implantable pulse generator | Device | Epilepsy |
Primary outcome
Adverse events (AE) experienced with the RC+S system
Time frame: Through 15 months
Number of AEs reported
24/7 continuous iEEG monitoring
Time frame: Through 15 months
Number of RC+S systems that generates continues 24/7 EEG without interruption
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
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
Tracking cognition
Time frame: Baseline, biweekly for up to 15 months
Measured using free recall task
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 38662736Balzekas 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.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Worrell principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Summit System, Olympus in people with Epilepsy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) experienced with the RC+S system (time frame: Through 15 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.