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
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
S
Swebilius Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Pulsed Low-Intensity Focused Ultrasound (PLIFU) to reduce or suppress seizure activity in adults experiencing non-convulsive or focal motor status epilepticus (SE) who have not responded to standard treatments. The study focuses on brain regions that generate or control seizures, aiming to assess the effects of this non-invasive brain stimulation in a hospital setting. Participants will receive up to two sessions of PLIFU treatment in the Intensive Care Unit. Each session lasts 10 minutes and uses a custom device that delivers ultrasound to specific brain areas without damaging tissue. Treatments will be given after anti-seizure medications have been administered, and the ultrasound is applied using safe, non-thermal settings. During the study, participants will be monitored continuously with surface EEG to measure epileptic brain activity before, during, and after PLIFU treatment. Researchers will observe changes in seizure activity and follow participants throughout their hospital stay. The main outcome is the change in epileptiform activity measured by EEG at baseline and 10 minutes after treatment. The study aims to gather preliminary data to support future research.
CONDITIONS
Brief Title
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects diagnosed with ongoing non-convulsive status epilepticus (NCSE) or focal motor status epilepticus (FMSE) despite treatment with at least 2 anti-seizure medications (ASMs)
- Provision of signed and dated informed consent form obtained from the next-of-kin or legally authorized representative
- Treated in the Intensive Care Unit (ICU) while monitored with continuous scalp EEG electrodes
You will not qualify if you...
- 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 hours
- Presence of burr hole(s) or craniotomy
- Presence of ferromagnetic materials in the head
- Presence of a TENS unit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants receive up to 2 sessions of PLIFU treatment on the same day while being monitored with surface EEG.
1 day with up to 2 treatment sessions
Duration - Varies depending on hospital stay
Participants are observed for the remainder of their hospital stay as deemed by the primary care team.
Ongoing monitoring during hospital stay
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
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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