Actively Recruiting

Phase Not Applicable
Age: 19Years - 85Years
All Genders
NCT05784805

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

Led by Yale University · Updated on 2025-10-29

10

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

S

Swebilius Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with ongoing non-convulsive status epilepticus or focal motor status epilepticus despite treatment with at least 2 antiseizure medications
  • Signed informed consent obtained from next-of-kin or legally authorized representative
  • Receiving treatment in the Intensive Care Unit with continuous scalp EEG monitoring
Not Eligible

You will not qualify if you...

  • Unable to obtain informed consent
  • Presence of an implanted cranial neuromodulation device for epilepsy treatment
  • Pregnancy
  • Treatment with another investigational drug or intervention within the past 24 hours
  • Presence of burr hole(s) or craniotomy
  • Presence of ferromagnetic materials in the head
  • Use of a transcutaneous electrical nerve stimulation (TENS) unit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

Loading map...

Research Team

I

Imran Quraishi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here