Focal Epilepsy study: UNEEG SubQ device vs Preventative Medication
Official title Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
ClinicalTrials.gov ID: NCT07012148
What this study is testing
What is Preventative Medication (PM)?
An investigational nasal diazepam being studied to prevent seizures in focal epilepsy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a seizure‑forecasting system is safe, comfortable, and can give people more control with minimal extra medication.
- Who it's for
- Adults with focal or generalized epilepsy who still have at least two seizures a month despite trying two or more medications and whose seizures involve the temporal lobe.
- What's involved
- Participants will have a small electrode implanted under the skin above the ear, wear a smartwatch, and receive alerts about seizure risk. On high‑risk days they may use a fast‑acting nasal spray medication.
- Time commitment
- The study lasts one year: six months of data collection without alerts, followed by six months of risk alerts and medication use, with visits and travel to Mayo Clinic Rochester as needed.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over...
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, brain stimulator, or other medical device that...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.
- 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...
- 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.
- 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).
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Compensation & support
Some study-related costs may be covered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.