Low-intensity Focused Ultrasound for Drug-Resistant Epilepsy
This study is looking at a new treatment called low-intensity focused ultrasound (LIFU) neuromodulation using the NaviFUS System for people with drug-resistant temporal lobe epilepsy (DR-TLE). This is a type of epilepsy where seizures are not controlled by standard medications. The study wants to see if this treatment is safe, tolerable, and if it can help reduce seizures. Researchers will measure any side effects (adverse events) for up to 23 weeks. You might be able to join if you are 18 or older and have DR-TLE. This small study plans to enroll up to 8 participants.
- Study design
- This is a prospective, open-label, single-arm, multi-center pilot study. It plans to enroll a maximum of 8 participants.
- What's involved
- You would undergo a 2-month baseline observation period, keep an 8-week seizure diary, receive 6 FUS treatments over 3 weeks, and continue the seizure diary throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- There will be a 12-week follow-up period after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- Adverse events (AEs)up to 23 weeks
The incidence and severity of AEs associated with LIFU neuromodulation in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy.