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

Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05784805
• Other study ID #: 2000034504
• Secondary ID: No NIH funding
• Status: Suspended
• Phase: N/A
• Start date: June 24, 2023
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Seizures
• Status Epilepticus

Intervention

Device:
• PLIFU
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Swebilius Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 10 minutes