Focal EpilepsyEarly Phase 1FORESITENCT07012148
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
A Early Phase 1 study testing UNEEG SubQ device, seizure forecasts, nasal diazepam and Preventative Medication (PM) in people with Focal Epilepsy and Generalized Seizure, run by Mayo Clinic at 3 sites in United States.
Trial summary
Mayo Clinic is conducting a research study to test a new approach to managing seizures in people with epilepsy whose seizures have not been fully controlled with regular medications. The study uses a small sensor placed just under the skin (not inside the brain) that continuously records electrical brain activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Focal Epilepsy, Generalized Seizure, Drug Refractory Epilepsy
- What is being tested?
- UNEEG SubQ device, seizure forecasts, nasal diazepam and Preventative Medication (PM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2026to Dec 2029
- Phase
- Early Phase 1
- 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
- Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria:
- Focal epilepsy, including complex partial, and secondarily generalized seizures, including:
- disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over the preceding 3 months, established by verbal history or caregiver report.
- For 3 months prior to enrollment, subject's AED dosages have been stable (less than a 25% change in dosage) and subject has had at least two seizures per month, on average, with a seizure-free interval not to exceed 60 days. Seizures must be separated by a minimum of four hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
- With the exception of epilepsy, subject must be medically and neurologically stable.
- Age 18 to 75.
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- 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 subject or caregiver, and have a distinct EEG pattern that can be recorded using subscalp EEG over the frontotemporal head region, established by video-EEG monitoring.
- 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.
- Subject's seizure focus, based upon clinical semiology, scalp EEG, intracranial electroencephalographic (iEEG) findings, and/or neuroimaging, demonstrate consistent involvement of the temporal lobe with their EEG seizure pattern.
- Subject speaks and reads English.
- Subject has no reason to anticipate requiring a magnetic resonance imaging (MRI) evaluation within the next two years.
- Subject has EEG documentation of ictal events consistent with his or her predominant current seizure type.
- Subject's anatomy will permit implantation of the UNEEG SubQ device in the opinion of the study's neurosurgeon.
- Female subjects have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.
Who cannot join
- For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.
- Subject needs to have magnetic resonance imaging during the study period.
- 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, brain stimulator, or other medical device that would interfere with the UNEEG device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, and cochlear implants. Vagus nerve stimulators are not expected to interfere with the subscalp EEG device and will be permitted, as long as stimulation parameters can be reasonably expected to remain stable (25% or less change in amplitude) throughout the study.
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- Subject has experienced unprovoked status epilepticus.
- Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement in the judgement of the neurosurgeon.
- Subject is on anticoagulants and is unable to discontinue them perisurgically, 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. Blood tests to evaluate platelet and bleeding disorder issues will be obtained prior to enrollment.
- Subject is otherwise ineligible for cranial surgery, or the Investigators identify other medical or psychosocial factors that would counter indicate participation in the study.
- Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)
- Female subject is pregnant or plans to become pregnant.
- Subject is known to require rescue medication for seizure clusters
- Subject has a history of a paradoxical reaction to benzodiazepines including agitation, hyperactivity, or aggression.
- Subject has a known diagnosis of acute narrow-angle glaucoma
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Brin Freund, MD, 904-953-2903, FLAEPILEPSY@mayo.edu
Brin Freund, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Benjamin H Brinkmann
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Kayla Haeger, RN, 480-342-5075, Haeger.Kayla@mayo.edu
Katherine Noe, MD, PhD
About this study
Official title: FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables
Mayo Clinic is conducting a research study to test a new approach to managing seizures in people with epilepsy whose seizures have not been fully controlled with regular medications. The study uses a small sensor placed just under the skin (not inside the brain) that continuously records electrical brain activity. This information is used to train a personalized computer algorithm that learns your individual seizure patterns and forecasts when a seizure is more likely to occur. If you are eligible and choose to participate, you would receive advance warning of elevated seizure risk, allowing you to take a fast-acting medication before a seizure happens. This medication would be in addition to the regular medicines prescribed by your doctor. The goal of the study is to understand whether this kind of forecasting system is safe, comfortable to live with, and capable of helping people gain more control over their seizures with a minimum amount of additional medication.
Participation involves a minor surgical procedure to implant a small electrode under the skin above your ear that records your brain's electrical signals continuously over time. You would also wear a smart watch during the study. For the first six months, the system collects data to personalize your seizure forecast model and would not give you an alert. In the second six months, we would calculate your daily seizure risk and you would receive alerts on days when your risk is elevated. On these higher seizure risk days you would take a prescribed fast-acting nasal spray medication. The study is open to adults who continue to have 2 or more seizures per month in spite of having tried at least two antiseizure medications in the past, and whose seizures have shown involvement of the temporal lobe. All study-related procedures, devices, and study medication are provided at no cost to participants. Participants receive financial compensation for their time, and travel expenses to and from Mayo Clinic Rochester are reimbursed for anyone traveling more than 100 miles. If you are interested in learning more, please contact our research coordinator by email at Laivell.Jeffrey@mayo.edu.
Read the detailed description
For most people with epilepsy, seizures do not appear to happen on a predictable schedule, but recent research shows that seizure risk may actually rise and fall in patterns over time, similar to other body rhythms. Right now, most people with drug-resistant epilepsy (epilepsy that has not responded well to medications) take antiseizure medication every day, whether or not their seizure risk is high that day, which means they deal with side effects every day even though seizures happen only sometimes. This study tests using a small implanted sensor and a wearable device to predict when a person's seizure risk is elevated, and then giving a fast-acting medication in advance, before a seizure happens. The goal is to find out whether this approach is safe and workable in everyday life.
This study will enroll adults with drug-resistant epilepsy that involves the temporal lobe, at Mayo Clinic in Rochester, Minnesota, Jacksonville, Florida, and Phoenix, Arizona.
Each participant has a small device called the UNEEG SubQ placed just under the scalp, in a minor surgical procedure. This device does not go into the brain itself. It sits under the skin and continuously records the brain's electrical activity. Participants also wear an smart watch to track heart rate and movement, and they keep a daily seizure diary on a smartphone.
The study takes place over about 12 months for each participant, in three parts.
Part 1, the first three months: The device and watch collect data in the background. No warnings or predictions are shown to the participant during this time. This information is used to build a personalized computer model that learns each person's individual patterns of seizure risk. For four weeks during this period, participants take a scheduled dose of VALTOCO (a nasal spray form of the medication diazepam) once a week, which helps the research team see how the medication affects the recorded brain activity.
Part 2, the next three months: The personalized computer model starts making daily predictions about seizure risk, but these predictions are reviewed only by the research team and are not shown to the participant yet. This lets the team check how accurate the predictions are before relying on them. As in Part 1, participants take one scheduled weekly dose of VALTOCO during a four week period.
Part 3, the final six months: Starting at a mid-study visit, participants begin receiving the daily predictions on their smartphone. On days when the model predicts a higher chance of seizures, the participant (or a caregiver) receives an alert and is asked to use VALTOCO nasal spray at that time, before a seizure occurs, rather than waiting for one to happen. To help keep the medication use safe, participants cannot use VALTOCO more than 10 times in a month, and the system will not allow the medication to be used on two days in a row.
At the end of the study, the implanted device is removed in a simple outpatient procedure and all study equipment is returned.
The main goal is to find out whether this forecast-guided approach to using rescue medication is safe and practical to use in daily life.
As additional goals, the study will also look at whether participants' quality of life and the impact epilepsy has on their daily life improve during the study, using standard questionnaires, and whether the rate of seizures during the final six month part of the study is lower than each participant's own personal baseline rate measured earlier in the study.
This study is conducted with authorization from the U.S. Food and Drug Administration under Investigational New Drug application number 170383, which allows the research team to study VALTOCO for this new, investigational use. The study is supported by a grant from the National Institutes of Health (UG3NS123066).
- Being tested
- UNEEG SubQ device, seizure forecasts, nasal diazepam, Preventative Medication (PM)
- Keywords
- complex partial seizure, UNEEG, seizure forecasting, Subscalp EEG, Benzodiazepine
- Medical subject headings
- Epilepsies, Partial, Seizures, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNEEG SubQ device, seizure forecasts, nasal diazepamDevice
Subjects will be implanted with the UNEEG SubQ device in the neurosurgical operating suite. Electrodes will be placed over the temporal lobe of the hemisphere established as the origin of seizures by previous EEG monitoring. Only one UNEEG device will be placed, and only the seizure onset hemisphere will be covered. Subjects will have individualized seizure forecast models created, and will take a supplemental antiseizure medicine during periods of elevated seizure risk.
Preventative Medication (PM)Drug
Subjects will take nasal diazepam in response to pre-seizure alerts to evaluate the potential for this medication to prevent seizures.
| Study group | Role | What they receive |
|---|---|---|
| subscalp EEG | Experimental | All study subjects will be implanted with the UNEEG SubQ device and will receive forecasts of daily seizure risk. Receives: Device: UNEEG SubQ device, seizure forecasts, nasal diazepam; Drug: Preventative Medication (PM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events
VALTOCO discontinuation rate due to TEAE below 10% of subjects
Measured: 12 months
Safety- cardiorespiratory events
no observed drug-related serious cardiorespiratory events
Measured: 12 months
Feasibility outcome
greater than 75% data collection adherence (18 hours/day) with the UNEEG and Apple Watch systems on average during the prospective forecasting portion of the study for over 90% of participants
Measured: 12 months
Preseizure alert feasibility
greater than 80% of pre-seizure alerts resulting in VALTOCO administration within 90 minutes in over 90% of participants
Measured: 12 months
Secondary outcomes (3)
Reduction in seizure rates during the prospective phase of the trial compared to baseline
For each subject, we will compare detected seizure rates during the Training and Validation phases (baseline) to rates during the prospective forecast-triggered VALTOCO phase, and report the per-subject change.
Measured: 12 months
Quality of Life Inventory and seizure related impact scores
Change in quality of life in the prospective phase of the trial compared to baseline: Measures determined from the QUOLIE-31
Measured: Baseline, 6 months, 12 months
Seizure related severity score
Change in seizure severity score in the prospective phase of the trial compared to baseline: Measures determined from the SERIAS (Foster, Conquest et al. 2025) neuropsychometric test
Measured: Baseline, 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start20 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Focal 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants will be implanted with a subscalp EEG system. Personalized seizure forecasting algorithms will be developed, and this will be used to prompt subjects to take a supplemental antiseizure medicine.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Benjamin H. Brinkmann, Mayo Clinic
- Investigators
- Benjamin Brinkmann, PhD, Principal investigator, Mayo ClinicGregory A Worrell, MD, PhD, Principal investigator, Mayo ClinicJamie J Van Gompel, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012148
- Sponsor's protocol ID
- 23-005125
- Other IDs
- UG3NS123066-02
- Acronym
- FORESITE
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cloyd J, Haut S, Carrazana E, Rabinowicz AL. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021 Apr;62(4):846-856. doi: 10.1111/epi.16847. Epub 2021 Feb 22.
PubMed 33617690Pal Attia T, Viana PF, Nasseri M, Duun-Henriksen J, Biondi A, Winston JS, P Martins I, Nurse ES, Dumpelmann M, Worrell GA, Schulze-Bonhage A, Freestone DR, Kjaer TW, Brinkmann BH, Richardson MP. Seizure forecasting using minimally invasive, ultra-long-term subcutaneous EEG: Generalizable cross-patient models. Epilepsia. 2023 Dec;64 Suppl 4(Suppl 4):S114-S123. doi: 10.1111/epi.17265. Epub 2022 May 4.
PubMed 35441703Viana PF, Pal Attia T, Nasseri M, Duun-Henriksen J, Biondi A, Winston JS, Pavao Martins I, Nurse ES, Dumpelmann M, Schulze-Bonhage A, Freestone DR, Kjaer TW, Richardson MP, Brinkmann BH. Seizure forecasting using minimally invasive, ultra-long-term subcutaneous electroencephalography: Individualized intrapatient models. Epilepsia. 2023 Dec;64 Suppl 4(Suppl 4):S124-S133. doi: 10.1111/epi.17252. Epub 2022 Apr 16.
PubMed 35395101Nasseri M, Stirling RE, Viana PF, Cui J, Nurse E, Karoly PJ, Kremen V, Dumpelmann M, Worrell GA, Freestone DR, Richardson MP, Brinkmann BH. Forecasting epileptic seizures with wearable devices: A hybrid short- and long-horizon pseudo-prospective approach. Epilepsia. 2025 Sep;66(9):3293-3308. doi: 10.1111/epi.18466. Epub 2025 May 24.
PubMed 40411751
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables
- ClinicalTrials.gov ID
- NCT07012148
- Acronym / sponsor ID
- FORESITE / 23-005125
- Keywords
- complex partial seizure, UNEEG, seizure forecasting, Subscalp EEG, Benzodiazepine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Jun 2025 (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.
Mayo Clinic is conducting a research study to test a new approach to managing seizures in people with epilepsy whose seizures have not been fully controlled with regular medications. The study uses a small sensor placed just under the skin (not inside the brain) that continuously records electrical brain activity. This information is used to train a personalized computer algorithm that learns your individual seizure patterns and forecasts when a seizure is more likely to occur. If you are eligible and choose to participate, you would receive advance warning of elevated seizure risk, allowing you to take a fast-acting medication before a seizure happens. This medication would be in addition to the regular medicines prescribed by your doctor. The goal of the study is to understand whether this kind of forecasting system is safe, comfortable to live with, and capable of helping people gain more control over their seizures with a minimum amount of additional medication.
Participation involves a minor surgical procedure to implant a small electrode under the skin above your ear that records your brain's electrical signals continuously over time. You would also wear a smart watch during the study. For the first six months, the system collects data to personalize your seizure forecast model and would not give you an alert. In the second six months, we would calculate your daily seizure risk and you would receive alerts on days when your risk is elevated. On these higher seizure risk days you would take a prescribed fast-acting nasal spray medication. The study is open to adults who continue to have 2 or more seizures per month in spite of having tried at least two antiseizure medications in the past, and whose seizures have shown involvement of the temporal lobe. All study-related procedures, devices, and study medication are provided at no cost to participants. Participants receive financial compensation for their time, and travel expenses to and from Mayo Clinic Rochester are reimbursed for anyone traveling more than 100 miles. If you are interested in learning more, please contact our research coordinator by email at Laivell.Jeffrey@mayo.edu.
Detailed description
For most people with epilepsy, seizures do not appear to happen on a predictable schedule, but recent research shows that seizure risk may actually rise and fall in patterns over time, similar to other body rhythms. Right now, most people with drug-resistant epilepsy (epilepsy that has not responded well to medications) take antiseizure medication every day, whether or not their seizure risk is high that day, which means they deal with side effects every day even though seizures happen only sometimes. This study tests using a small implanted sensor and a wearable device to predict when a person's seizure risk is elevated, and then giving a fast-acting medication in advance, before a seizure happens. The goal is to find out whether this approach is safe and workable in everyday life.
This study will enroll adults with drug-resistant epilepsy that involves the temporal lobe, at Mayo Clinic in Rochester, Minnesota, Jacksonville, Florida, and Phoenix, Arizona.
Each participant has a small device called the UNEEG SubQ placed just under the scalp, in a minor surgical procedure. This device does not go into the brain itself. It sits under the skin and continuously records the brain's electrical activity. Participants also wear an smart watch to track heart rate and movement, and they keep a daily seizure diary on a smartphone.
The study takes place over about 12 months for each participant, in three parts.
Part 1, the first three months: The device and watch collect data in the background. No warnings or predictions are shown to the participant during this time. This information is used to build a personalized computer model that learns each person's individual patterns of seizure risk. For four weeks during this period, participants take a scheduled dose of VALTOCO (a nasal spray form of the medication diazepam) once a week, which helps the research team see how the medication affects the recorded brain activity.
Part 2, the next three months: The personalized computer model starts making daily predictions about seizure risk, but these predictions are reviewed only by the research team and are not shown to the participant yet. This lets the team check how accurate the predictions are before relying on them. As in Part 1, participants take one scheduled weekly dose of VALTOCO during a four week period.
Part 3, the final six months: Starting at a mid-study visit, participants begin receiving the daily predictions on their smartphone. On days when the model predicts a higher chance of seizures, the participant (or a caregiver) receives an alert and is asked to use VALTOCO nasal spray at that time, before a seizure occurs, rather than waiting for one to happen. To help keep the medication use safe, participants cannot use VALTOCO more than 10 times in a month, and the system will not allow the medication to be used on two days in a row.
At the end of the study, the implanted device is removed in a simple outpatient procedure and all study equipment is returned.
The main goal is to find out whether this forecast-guided approach to using rescue medication is safe and practical to use in daily life.
As additional goals, the study will also look at whether participants' quality of life and the impact epilepsy has on their daily life improve during the study, using standard questionnaires, and whether the rate of seizures during the final six month part of the study is lower than each participant's own personal baseline rate measured earlier in the study.
This study is conducted with authorization from the U.S. Food and Drug Administration under Investigational New Drug application number 170383, which allows the research team to study VALTOCO for this new, investigational use. The study is supported by a grant from the National Institutes of Health (UG3NS123066).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants will be implanted with a subscalp EEG system. Personalized seizure forecasting algorithms will be developed, and this will be used to prompt subjects to take a supplemental antiseizure medicine.
| Arm | Type | Receives |
|---|---|---|
| subscalp EEG | Experimental | Device: UNEEG SubQ device, seizure forecasts, nasal diazepam, Drug: Preventative Medication (PM)All study subjects will be implanted with the UNEEG SubQ device and will receive forecasts of daily seizure risk. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria:
- Focal epilepsy, including complex partial, and secondarily generalized seizures, including:
- With the exception of epilepsy, subject must be medically and neurologically stable.
- 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 (16 listed)
- For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.
- Subject needs to have magnetic resonance imaging during the study period.
- 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 |
|---|---|---|
| UNEEG SubQ device, seizure forecasts, nasal diazepamSubjects will be implanted with the UNEEG SubQ device in the neurosurgical operating suite. Electrodes will be placed over the temporal lobe of the hemisphere established as the origin of seizures by previous EEG monitoring. Only one UNEEG device will be placed, and only the seizure onset hemisphere will be covered. Subjects will have individualized seizure forecast models created, and will take a supplemental antiseizure medicine during periods of elevated seizure risk. | Device | subscalp EEG |
| Preventative Medication (PM)Subjects will take nasal diazepam in response to pre-seizure alerts to evaluate the potential for this medication to prevent seizures. | Drug | subscalp EEG |
Primary outcome
Safety and Adverse Events
Time frame: 12 months
VALTOCO discontinuation rate due to TEAE below 10% of subjects
Safety- cardiorespiratory events
Time frame: 12 months
no observed drug-related serious cardiorespiratory events
Feasibility outcome
Time frame: 12 months
greater than 75% data collection adherence (18 hours/day) with the UNEEG and Apple Watch systems on average during the prospective forecasting portion of the study for over 90% of participants
Preseizure alert feasibility
Time frame: 12 months
greater than 80% of pre-seizure alerts resulting in VALTOCO administration within 90 minutes in over 90% of participants
3 secondary outcomes
Reduction in seizure rates during the prospective phase of the trial compared to baseline
Time frame: 12 months
Quality of Life Inventory and seizure related impact scores
Time frame: Baseline, 6 months, 12 months
Seizure related severity score
Time frame: Baseline, 6months, 12months
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 25 Sep 2026.
- Background: PubMed 33617690Cloyd J, Haut S, Carrazana E, Rabinowicz AL. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021 Apr;62(4):846-856. doi: 10.1111/epi.16847. Epub 2021 Feb 22.
- Background: PubMed 35441703Pal Attia T, Viana PF, Nasseri M, Duun-Henriksen J, Biondi A, Winston JS, P Martins I, Nurse ES, Dumpelmann M, Worrell GA, Schulze-Bonhage A, Freestone DR, Kjaer TW, Brinkmann BH, Richardson MP. Seizure forecasting using minimally invasive, ultra-long-term subcutaneous EEG: Generalizable cross-patient models. Epilepsia. 2023 Dec;64 Suppl 4(Suppl 4):S114-S123. doi: 10.1111/epi.17265. Epub 2022 May 4.
- Background: PubMed 35395101Viana PF, Pal Attia T, Nasseri M, Duun-Henriksen J, Biondi A, Winston JS, Pavao Martins I, Nurse ES, Dumpelmann M, Schulze-Bonhage A, Freestone DR, Kjaer TW, Richardson MP, Brinkmann BH. Seizure forecasting using minimally invasive, ultra-long-term subcutaneous electroencephalography: Individualized intrapatient models. Epilepsia. 2023 Dec;64 Suppl 4(Suppl 4):S124-S133. doi: 10.1111/epi.17252. Epub 2022 Apr 16.
- Background: PubMed 40411751Nasseri M, Stirling RE, Viana PF, Cui J, Nurse E, Karoly PJ, Kremen V, Dumpelmann M, Worrell GA, Freestone DR, Richardson MP, Brinkmann BH. Forecasting epileptic seizures with wearable devices: A hybrid short- and long-horizon pseudo-prospective approach. Epilepsia. 2025 Sep;66(9):3293-3308. doi: 10.1111/epi.18466. Epub 2025 May 24.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Benjamin Brinkmann, PhD principal investigator
Mayo Clinic
Gregory A Worrell, MD, PhD principal investigator
Mayo Clinic
Jamie J Van Gompel, MD study director
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UNEEG SubQ device, seizure forecasts, nasal diazepam and Preventative Medication (PM) in people with Focal Epilepsy and Generalized Seizure, run by Mayo Clinic at 3 sites 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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jeff Laivell (507-538-8095, laivell.jeffrey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (time frame: 12 months). The study lists 4 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 NCT07012148, which also lists 4 linked publications.
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 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.