The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on … (NCT05032105) | Clinical Trial Compass
Active — Not RecruitingPhase 1
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
United States2 participantsStarted 2024-06-04
Plain-language summary
The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients suffering from treatment-refractory focal epilepsy and anxiety. FUSA is a non-invasive neurosurgical procedure that uses ultrasound waves, sent directly through the scalp and skull, to precisely target small abnormal areas of the brain. For this study, the targeted area of the brain is the anterior nucleus of the thalamus. This brain region may cause seizures and may also be involved in anxiety. The study will test if FUSA is safe and tolerated, and if it reduces anxiety and brain response to threat in patients with anxiety receiving the procedure for partial-onset epilepsy that is resistant to medications.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
* Focal onset seizures with secondary generalization; with or without primary generalized seizures.
* Previous seizure work-up within 12 months of enrollment date to include:
A. Home EEG or EMU video EEG or intracranial EEG. B. High definition MRI imaging/PET imaging. C. Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF).
* ≥ 3 seizures/month on average within 3 months of enrollment.
* Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
* Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score \> 17.
* Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
* Willing to maintain seizure diary (3 months before \& 3 months after).
* Involved care provider.
* Written informed consent to participate.
* Ability to comply with all testing, follow-ups, and study appointments and protocols.
Exclusion Criteria:
* Low seizure frequency (\<3 seizures/month).
* Generalized epilepsy (Lennox Gastaut, drop attacks).
* Post infectious epilepsy (post herpetic).
* Unable or unwilling to maintain anti-epilepsy drug dosage for 3 months post treatment.
* Active (current in past 12 months), uncontrolled DSM-5 psychiatric disorder, except for anxiety disorders.
* Recent (past 12 months) history …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.