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

Recruiting

Who can join

Ages 19 to 85 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Yale University · Participants: 10 · Started: Jun 24, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05784805

Locations in the U.S.

ConnecticutYale New Haven Hospital, New Haven

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.