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

Primary Purpose

Seizures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PLIFU
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with ongoing non-convulsive or focal motor SE

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
June 26, 2023
Sponsor
Yale University
Collaborators
Swebilius Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05784805
Brief Title
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Official Title
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Swebilius Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with ongoing non-convulsive or focal motor SE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PLIFU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in epileptiform activity
Description
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.
Time Frame
baseline and 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David King-Stephens, MD
Phone
203-710-4361
Email
david.king-stephens@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David King-Stephens, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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