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

• Sponsor: Yale University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05784805
• Collaborator: Swebilius Foundation (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seizures	Device: PLIFU	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Outcome Measures

Primary Outcome Measures

1. Change in epileptiform activity [baseline and 10 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Yale University
• Swebilius Foundation

Investigators

• Principal Investigator: David King-Stephens, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05784805
• Other Study ID Numbers: 2000034504
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures; Status Epilepticus

Study Results

No Results Posted as of Mar 27, 2023