What is PLIFU studying for seizures?

PLIFU is being studied to see if it can reduce or suppress seizure activity in patients with non-convulsive or focal motor status epilepticus who have not responded to standard treatments. This research is led by Yale University and focuses on a non-invasive brain stimulation method using focused ultrasound.

Who may be eligible for this seizures clinical trial?

Adults aged 19 to 85 with ongoing non-convulsive or focal motor status epilepticus despite treatment with at least two anti-seizure medications may be eligible. Participants must be in an ICU with continuous EEG monitoring and have consent provided by a legal representative. Please review eligibility criteria for more details.

Is there any cost to participate in this seizures clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 19Years - 85Years

All Genders

ID05784805

Using Focused Ultrasound to Reduce Seizures in Adults with Status Epilepticus Treatment Study in ICU Patients with Non-Convulsive or Focal Motor Seizures

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

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 19Years - 85Years

All Genders

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

Research Team

Imran Quraishi, MD

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