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 been assessed by a team of clinicians and are thought to have a specific type of epilepsy affecting a region of the brain called the hippocampus (referred to as EPH in the trial).
• People who are able to follow test instructions and give their informed agreement to take part — generally, this means having a level of cognitive ability roughly equivalent to an IQ of 65 or above.
• People whose verbal memory (the ability to remember spoken or written information) falls within a normal range, as measured by formal testing with a neuropsychologist — specifically, within 1.5 standard deviations of the average score.
• People who are proficient in English, as all tasks and consent forms used in the trial are in English.
• People aged between 18 and 65 years.
• People who experience at least 2 seizures of any type per month, so that the effect of the treatment can be measured over a shorter period of time.
• People who have secondary generalised seizures may also be considered, provided they had no more than 20 generalised seizures in the 12 months before enrolling, or an average of no more than 3 generalised seizures per month.

Who may not be able to join:

• People with significant impairment in reading or cognitive function — generally, more than 3 standard deviations below the average on neuropsychological testing, or roughly an IQ below 60.
• People who have a major structural abnormality in the brain, such as a tumour, vascular malformation, hamartoma, or widespread developmental abnormality of the brain's surface, that may suggest a more complex epilepsy network.
• People with certain neurological conditions, including a stroke, brain infection (encephalitis), or meningitis within the past 5 years, or anyone currently diagnosed with these conditions.
• People who have had an episode of prolonged or continuous seizure activity (status epilepticus) at any point in the 12 months before enrolling.
• People with a significant and uncontrolled psychiatric condition that would prevent meaningful participation in the trial.
• People who score 29 or higher on the Beck Depression Inventory II — a standardised questionnaire used to measure the severity of depression — at their initial assessment (indicating severe depression).
• People who have attempted suicide in the 12 months before enrolling.
• People whose memory difficulties are caused by other neurological conditions, such as dementia or Parkinson's disease.
• People who are not able to speak or understand English.
• People who have a cardiac pacemaker, intracranial aneurysm clips, or other implanted metal devices that the manufacturer considers to be incompatible with MRI scanning.
• People with severe shrinkage and scarring of most of the hippocampus (equivalent to what is classified as ILAE Type III hippocampal sclerosis).
• People who have previously had brain surgery for any reason, or who have previously had a brain stimulation device that did not work — note that prior vagus nerve stimulation (VNS) therapy may be acceptable, provided the settings remain unchanged throughout the trial.
• People who have a history of, or are currently experiencing, non-epileptic seizure-like episodes, as this may affect the accuracy of seizure monitoring during the trial.
• People who are pregnant. Women of childbearing potential will be counselled about the unknown risks to a fetus and the importance of using contraception during the trial. If a participant becomes pregnant during the trial, the trial site will move them to a standard, regulatory-approved treatment setting.

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