Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
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
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