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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Contact Information
Primary
Imran Quraishi, MD
imran.quraishi@yale.edu
(203) 785-3865
Time Frame
Start Date: 2023-06-24
Estimated Completion Date: 2026-02
Participants
Target number of participants: 10
Treatments
Experimental: Participants with ongoing non-convulsive or focal motor SE
Adult patients with ongoing non-convulsive or focal motor SE despite treatment with at least 2 ASMs and who are monitored with surface EEG will be screened and enrolled to receive up to 2 sessions of PLIFU.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Swebilius Foundation

This content was sourced from clinicaltrials.gov