Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 3:33 PM
Study NCT ID:
NCT05784805
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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), 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.
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.
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 Intensive Care Unit (ICU): 1) non-convulsive SE or 2) focal motor Status Epilepticus (SE), targeting the thalami or motor cortical areas responsible for generating ictal activity, respectively.
PLIFU modulation is non-ablative, nonionizing, and noninvasive, while it also preserves the integrity and function of brain tissue. The aim is to quantify ictal and interictal EEG before, during, and after sonication. Experiments will not alter the standard of care and only be implemented after antiseizure medications (ASMs) have been delivered to the patient. PLIFU sonication will be delivered to participants using burst tone and nonthermal parameters for 10 minute exposures.
Hypothesis: PLIFU is a safe and non-invasive treatment that can reduce or suppress epileptic activity.
The pilot data acquired is intended to 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.
PLIFU modulation is non-ablative, nonionizing, and noninvasive, while it also preserves the integrity and function of brain tissue. The aim is to quantify ictal and interictal EEG before, during, and after sonication. Experiments will not alter the standard of care and only be implemented after antiseizure medications (ASMs) have been delivered to the patient. PLIFU sonication will be delivered to participants using burst tone and nonthermal parameters for 10 minute exposures.
Hypothesis: PLIFU is a safe and non-invasive treatment that can reduce or suppress epileptic activity.
The pilot data acquired is intended to 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No NIH funding | OTHER | 12.06.23 | View |