RecruitingNot ApplicableNCT05784805

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

Sponsor

Yale University

Enrollment

10 participants

Start Date

Jun 24, 2023

Study Type

INTERVENTIONAL

Conditions

Seizures

Summary

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.

Eligibility

Min Age: 19 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria7

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

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Interventions

DEVICEPLIFU

Participants will be treated with up to 2 sessions of PLIFU (on the same day), while monitored with surface EEG and will be observed for the remainder of the hospital stay as deemed by the primary care team. The system non-invasively delivers ultrasound sonications intracranially that selectively target specific areas of the brain.