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

NCT05784805 | Recruiting

• 2 other identifiers: 2000034504No NIH funding
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants with ongoing non-convulsive or focal motor SE

EXPERIMENTAL

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

Interventions

PLIFU DEVICE

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.

Participants with ongoing non-convulsive or focal motor SE

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Swebilius Foundation: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Imran Quraishi, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Quraishi, MD

CONTACT

(203) 785-3865; imran.quraishi@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: June 24, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)