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New treatment option for Focal Epilepsy
Official title Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
ClinicalTrials.gov ID: NCT07012148
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.
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
- people enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years...
- 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...
- 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.
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
Who can join
- people 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...
- 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.
What rules you out
- 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. This includes, but is not limited...
- 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...
- 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 is pregnant or intends to become pregnant during the study period.
- Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)
- Female subject is pregnant or plans to become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 - 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?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.