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

StatusRecruiting
PhaseNot applicable
Started2023-06-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Feb 2026 → Dec 2026
See other at-risk trials from Yale University

Amendment history

2026-09-22
Primary completion pushed: 2026-02 → 2026-12
Completion pushed: 2026-02 → 2026-12
2025-10-27
Study Status v5
Re-verified, no change to tracked fields
2024-10-01
Suspended→Recruiting Study Status, Study Description, Contacts/Locations v4
Trial statusSuspended→Recruiting
Reason stoppedStudy recruitment is on hold due to personnel changes and modifications.→not stated
Primary completion date2024-03→2026-02
Completion date2024-03→2026-02
Study description+126 characters
[...] o be used as preliminary data for justifying a larger study. Recruitment was put on hold from Dec. 2023 to Oct. 2024 due to personnel changes and modifications to study needing approval.
Study sitesdetails revised at 1 of 1 site
2023-12-20
Recruiting→Suspended Study Identification, Study Status, Contacts/Locations v3
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study recruitment is on hold due to personnel changes and modifications.
Primary completion date2023-10→2024-03
Completion date2023-10→2024-03
Study sitesdetails revised at 1 of 1 site
2023-06-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06→confirmed 2023-06-24
Study sitesdetails revised at 1 of 1 site
2023-05-22
Study Status v1
Primary completion date2023-08→2023-10
Completion date2023-08→2023-10
Start date2023-04→2023-06
2023-03-13
Original filing
Yale University
487 trials monitored
See 35 trials at risk
Epilepsy
723 trials monitored
See 41 trials at risk
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.
Trial Details
NCT Number NCT05784805
Lead Sponsor Yale University
Collaborators: Swebilius Foundation
Conditions Seizures
Enrollment 10 participants
Start Date 2023-06-24
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-21