Epilepsy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have epilepsy involving the temporal lobe (a specific part of the brain) and have had video-EEG brain monitoring done within the past 3 years.
• People whose seizures are "focal" (starting in one area of the brain), including seizures that cause loss of awareness or spread to affect the whole body.
• People who have had at least 2 disabling seizures per month on average over the past 3 months — where "disabling" means the seizure causes loss of awareness, loss of motor control, loss of speech, or loss of another essential function.
• People whose seizure medication doses have been stable (changed by less than 25%) for the 3 months before joining, and who have had at least 2 seizures per month with no seizure-free gap longer than 60 days during that time.
• People who are otherwise medically and neurologically stable, apart from their epilepsy.
• People aged 18 to 75.
• People who are able and willing to give informed consent and follow the study requirements, including responding to signals from the study device.
• People whose seizures follow a clear, consistent pattern that can be reliably counted by themselves or a caregiver, and that show a distinct pattern on EEG recordings from the front-side area of the head.
• People who are able to keep a seizure diary, either on their own or with help from a reliable person.
• People who are able to attend regular clinic visits and telephone check-ins as required by the study.
• People whose seizure activity, based on brain scans and EEG results, consistently involves the temporal lobe.
• People who speak and read English.
• People who do not expect to need an MRI scan within the next two years.
• People who have EEG records showing brain activity during seizures that match their usual seizure type.
• People whose head and scalp anatomy, in the opinion of the study's neurosurgeon, would allow the study device (UNEEG SubQ) to be implanted.
• Female participants who have a negative pregnancy test, do not plan to become pregnant, and agree to use effective contraception throughout the study.

Who may not be able to join:

• People whose seizure medication doses changed by more than 25% in the 3 months before enrolment, or who have had more than 30 disabling seizures per month on average, or more than 10 seizure days per month on average.
• People who may need an MRI scan at any point during the study period.
• People who have had a history of substance misuse (alcohol, prescription medications, or illicit drugs) within the past two years.
• People who have taken part in another drug or device clinical trial within the past 30 days.
• People who have been hospitalised for a psychiatric condition within the past two years, or who have had a history of psychosis within the past two years (not including psychosis that occurs directly after a seizure).
• People who already have an implanted medical device that could interfere with the study device, such as a pacemaker, heart defibrillator, brain stimulator, spinal cord stimulator, or cochlear implant. (Note: vagus nerve stimulators may be permitted if stimulation settings are expected to remain stable throughout the study.)
• People who have experienced unprovoked status epilepticus (a prolonged or repeated seizure emergency not triggered by an obvious cause).
• People who have previously had surgery to treat their epilepsy in a way that might affect where the study device's electrodes can be placed, in the neurosurgeon's judgement.
• People who take blood-thinning medications and are unable to stop taking them around the time of the implant procedure, as directed by the neurosurgeon or study investigator.
• People who have significant problems with how their blood platelets function, due to a medical condition or medications such as aspirin or sodium valproate — unless a blood specialist, the study investigator, and the neurosurgeon all agree it is safe to proceed after blood testing.
• People who are not suitable for cranial (head) surgery for any reason, or where the study investigators identify other medical or psychological factors that would make participation inadvisable.
• People who are pregnant or plan to become pregnant during the study period.
• People who have been diagnosed with psychogenic nonepileptic seizures (PNES) — seizures that are not caused by abnormal electrical activity in the brain.

Important: Always verify eligibility with the trial site directly before applying.