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

Description

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.

Conditions

Seizures

Study Overview

Study Details

Study overview

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.

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

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

Condition
Seizures
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

19 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Imran Quraishi, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-02