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Focused Ultrasound for Non-Convulsive or Focal Motor Seizures

This study is testing a new treatment called Pulsed Low-Intensity Focused Ultrasound (PLIFU) for people experiencing ongoing seizures that haven't responded to at least two standard seizure medications. These seizures are either non-convulsive (NCSE) or focal motor (FMSE). Researchers want to see if PLIFU can reduce or stop seizure activity by targeting specific brain areas. You would receive up to two PLIFU treatments on the same day while being monitored. The main goal is to see how much seizure activity changes within 10 minutes of treatment. This study is currently on hold until October 2024 due to personnel changes and needing approval for study modifications.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is a single-arm study, meaning all participants receive the PLIFU treatment.
What's involved
You would receive up to two 10-minute PLIFU treatment sessions on the same day. You will be monitored with continuous scalp EEG during treatment and observed for the rest of your hospital stay.
Compensation
Not stated in the trial record.
Follow-up
Your epileptiform activity will be measured at baseline and 10 minutes after treatment. You will be observed for the remainder of your hospital stay.

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NCT05784805

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

Recruiting
NAAges 19–85InterventionalTreatment
Yale University
~10 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:PLIFU

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in epileptiform activity
Measured over baseline and 10 minutes

Conditions

Seizures

Explore related trials

Status Epilepticus

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Imran Quraishi, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Imran Quraishi, MD
[email protected]
(203) 785-3865
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in epileptiform activitybaseline and 10 minutes

    To determine the effect of PLIFU (duration of 10 minutes) on epileptic activity in participants with NCSE/FMSE that have not responded to standard of care using continuous surface EEG. A reduction or suppression of epileptic activity indicates a positive outcome.