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

RecruitingNAAges 19 Years - 85 YearsAllYale University
NCT05784805 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 * 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
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What it tests

  • PLIFU
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Where

1 site
Yale New Haven Hospital
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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