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RECRUITING
NCT05784805
NA

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

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

19 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-06-24

Completion Date

2026-02

Last Updated

2025-10-29

Healthy Volunteers

No

Conditions

Interventions

DEVICE

PLIFU

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.

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States