Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
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
- PLIFU (device)
Sponsor: Yale University · Participants: 10 · Started: Jun 24, 2023
Contact the study team
- Imran Quraishi, MD · Phone: (203) 785-3865
Official record on ClinicalTrials.gov — NCT05784805
Locations in the U.S.
| Connecticut | Yale 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.