Status:
RECRUITING
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Lead Sponsor:
Yale University
Collaborating Sponsors:
Swebilius Foundation
Conditions:
Seizures
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief 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), ...
Detailed Description
This study proposes to sonicate epileptic zones or circuits at the bedside with a custom built PLIFU device in two groups of participants experiencing non-convulsive seizures while treated in the Inte...
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
Key Trial Info
Start Date :
June 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05784805
Start Date
June 24 2023
End Date
February 1 2026
Last Update
October 29 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520