Using focused ultrasound to reduce seizures in patients with status epilepticus
Official title: Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Run by Yale University · NCT05784805 · Data updated 2026-11-12
This study is testing whether a new ultrasound treatment can help reduce seizures in patients who haven't responded to regular medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 85 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | June 24, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT05784805 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with ongoing non-convulsive or focal motor status epilepticus despite treatment with at least two antiseizure medications.
✕Probably not a fit
Patients who are unable to provide informed consent or have certain medical devices or conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of Pulsed Low-Intensity Focused Ultrasound (PLIFU) on patients experiencing non-convulsive or focal motor status epilepticus who have not responded to standard treatments. Participants will receive a 10-minute session of PLIFU targeting specific brain regions associated with seizure activity while being monitored in the ICU. The primary goal is to assess whether this non-invasive technique can reduce or suppress epileptic activity as measured by EEG. The study aims to gather preliminary data to support future larger-scale investigations.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients with difficult-to-treat seizures.
How similar studies have gone: While focused ultrasound is a novel approach in this context, similar non-invasive techniques have shown promise in other neurological applications.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs * Provision of signed and dated informed consent form obtained from the next-of-kin/legally authorized representative * Treated in the ICU while monitored with continuous scalp EEG electrodes Exclusion Criteria: * Unable to obtain informed consent * Presence of an implanted cranial neuromodulation device for treatment of epilepsy * Pregnancy * Treatment with another investigational drug or other intervention within 24 hr * Presence of burr hole(s) or craniotomy * Subjects with ferromagnetic materials in the head * Subjects with a TENS unit
Where it's running
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Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Imran Quraishi, MD — Yale University
- Study coordinator: Imran Quraishi, MD
- Email: imran.quraishi@yale.edu
- Phone: (203) 785-3865
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.