Ultrasound therapy for drug-resistant temporal lobe epilepsy
Part of Brain & nervous system clinical trials.
This study tests if a new, non-invasive ultrasound treatment can safely reduce seizures in people whose seizures start in the temporal lobe and have not been controlled by at least two anti-epileptic drugs. The ultrasound is delivered through the scalp to gently stimulate the brain area where the seizures begin.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older.
- You have been diagnosed with drug-resistant epilepsy, meaning at least two anti-seizure medications have not stopped your seizures.
- Your seizures begin in the temporal lobe (part of the brain responsible for memory and emotions) and you can have up to two known seizure start areas, with at least one in the mesial temporal lobe.
- You have had at least 4 seizures that are noticeable or significantly affect your life during an 8-week observation period, and at least 1 seizure per month during that time.
- You have had an MRI and EEG within the past 3 years, and at least one prior EEG showed abnormal seizure activity.
- You are on a stable dose of your seizure medications for at least 30 days before starting the study.
- If you can become pregnant, you agree to use an acceptable form of contraception and have a negative pregnancy test before treatment.
- Your scalp needs to be clear of scars, skin conditions, or prior surgery at the area where the ultrasound will be applied, and you don't have metal clips or other metallic objects in your skull or brain (except shunts).
- You are able to complete study questionnaires in English (with or without an interpreter) and agree to shave the hair in the treatment area if needed.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This study tests a new device called NaviFUS that uses focused sound waves to gently stimulate a small area of the brain. It is for people whose seizures start in one part of the brain and are not fully controlled by seizure medicines.
This trial tests the NaviFUS system to treat seizures that keep happening despite seizure medicines, specifically in people with temporal lobe epilepsy. If you qualify, you would be carefully checked before and during the study, including seizure tracking and brain scans, to see whether treatment helps reduce seizures.
This pilot study tests whether low-intensity focused ultrasound can reduce seizures in adults whose temporal lobe epilepsy hasn’t improved with at least two anti-seizure medicines. You may be asked to track seizure timing and undergo brain imaging before and during the study.
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