A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy (NCT03417297)
A Pilot Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause seizures. Safety will be measured by recording and analyzing the frequency of side effects throughout participation. Feasibility will be measured by the ability to create a lesion in the anterior nucleus.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (16 items).
Location: University of North Carolina-Chapel Hill — Chapel Hill, North Carolina
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Have on average less than 3 seizures a month.
- Have an indwelling vagal nerve stimulator.
- Have severe untreated neuropsychiatric disorders (e.g., untreated depression or behavioral problems).
- History of drug or alcohol abuse in the last 12 months.
- Presence of primary generalized epilepsy (e.g., Lennox Gastaut, drop attacks).
- Presence of post-infectious epilepsy (i.e., epilepsy from post-herpetic encephalitis).
- Previous corpus callosotomy (surgery to cut the fibers, called the corpus callosum, that separate each half of the brain).
- Significant structural brain abnormalities.
- Unable or unwilling to maintain your current anti-seizure drug dosage for 3 months post-treatment.
- Pregnant or not practicing birth control methods.
- History of claustrophobia (fear of closed spaces).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of North Carolina-Chapel Hill — Chapel Hill, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Partial Seizures With Secondary Generalization clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.