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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

PLIFU
Device
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Participants with ongoing non-convulsive or focal motor SEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in epileptiform activity

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.

Time frame

baseline and 10 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Swebilius Foundation

Collaborator

Source ClinicalTrials.gov

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