NCT05784805 · Yale University
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
What this study 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.
View original scientific description
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.
Interventions
DEVICE
PLIFU
Participants will be treated with up to 2 sessions of PLIFU (on the same day), while monitored with surface EEG and will be observed for the remainder of the hospital stay as deemed by the primary care team. The system non-invasively delivers ultrasound sonications intracranially that selectively target specific areas of the brain.
Primary outcome measures
Change in epileptiform activity
Time frame: baseline 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Unable to obtain informed consent
- Presence of an implanted cranial neuromodulation device for treatment of epilepsy
- 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
Where
- New Haven, Connecticut
Collaborators
Swebilius Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations