Phase 2 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:

• You are 18 years of age or older
• You have been diagnosed with temporal lobe epilepsy that has not been controlled by trying at least two different seizure medications (used properly and at adequate doses)
• Your seizures start in a focused area of the brain, and you have no more than two of these starting points, with at least one being in the inner part of the temporal lobe
• You have had at least 4 seizures with visible or significantly disabling effects during an 8-week observation period, and at least one seizure per month during that time
• You have had a brain scan (MRI) and a brainwave test (EEG) within the past 3 years, and at least one EEG has shown signs of epileptic activity in a specific area
• The target area in your brain for the ultrasound treatment is located at least 30 mm (about 1.2 inches) below the surface of your skull (confirm with trial site)
• You have been on the same seizure medication(s) without changes for at least 30 days before joining, not counting emergency or occasional extra doses
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting and agree to use an effective form of birth control from before the first treatment until 3 months after the last treatment; this also applies to male participants whose partners could become pregnant
• You are willing to have the hair shaved in the area where the treatment device will be placed, or across your whole head if you prefer
• You are able to complete all study questionnaires in English, with the help of an interpreter if needed
• You (or your legal representative) are able to give written consent and follow the study requirements throughout the trial

Who may not be able to join:

• You have a type of epilepsy that affects the whole brain from the start, a mix of whole-brain and focal epilepsy, or a history of seizures that are not caused by epilepsy
• You have had a prolonged, continuous tonic-clonic seizure (full-body convulsion) in the 12 months before enrolling
• The only possible path for the ultrasound treatment to reach your brain passes through an area with previous surgery scars, skin conditions (such as eczema or psoriasis), thinned scalp, metal implants in the skull or brain (other than shunts), or a previous craniotomy (skull opening) site
• You have a brain condition that is actively changing or getting worse, such as a brain tumor, multiple sclerosis, dementia, or a blood vessel problem in the brain
• You have an electronic device implanted in your body, such as a heart pacemaker, defibrillator, medication pump, cochlear implant, or a brain stimulator (note: a vagus nerve stimulator may be allowed if its settings stay stable and it is turned off during each treatment session — confirm with trial site)
• You have severe depression, thoughts or behaviors related to suicide, active psychosis (not including brief post-seizure psychosis), or you were admitted to a psychiatric hospital in the year before enrolling
• Your IQ score is below 70, based on a standard intelligence test
• You have another serious health condition that would make it hard to follow the study requirements or affect the results
• You have taken part in another clinical trial using an experimental drug or device within the past 4 weeks
• You have had a specific type of brain procedure called radiofrequency thermocoagulation (RFTC) within 2 months before enrolling
• You have a known history of drug or alcohol misuse in the past year (not including marijuana)
• You are currently pregnant or breastfeeding
• There is any other reason the study doctor believes your participation could put you at risk or affect the quality of the study results (confirm with trial site)

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