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NCT05784805
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Conditions: Seizures
Sex: All
Ages: 19 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Yale University
Location: Yale New Haven Hospital New Haven Connecticut
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05784805). StuddyBuddy aggregates publicly available trial information.