Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
ConditionSeizures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorYale University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PLIFU
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Swebilius Foundation
Collaborator
Source ClinicalTrials.gov