Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients

Recruiting now · Not applicable

Conditions studied: Seizures

In brief

In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The course of treatment will consist of an initial 10 minute PLIFU treatment session with an option for a 2nd session if necessary. The primary objective of this study is to determine whether PLIFU reduces or suppresses epileptic activity in patients with Non-Convulsive Status Epilepticus (NCSE)/Focal Motor Status Epilepticus (FMSE) that have not responded to standard of care.

Key facts

Study ID: NCT05784805
Run by: Yale University
People needed: 10
Starts: 2023-06-24
Expected to finish: 2026-02-01
Last updated by the study team: 2025-10-29

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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