RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-24
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05784805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs
  2. * Provision of signed and dated informed consent form obtained from the next-of-kin/legally authorized representative
  3. * Treated in the ICU while monitored with continuous scalp EEG electrodes
  1. * Unable to obtain informed consent
  2. * Presence of an implanted cranial neuromodulation device for treatment of epilepsy
  3. * Pregnancy
  4. * Treatment with another investigational drug or other intervention within 24 hr
  5. * Presence of burr hole(s) or craniotomy
  6. * Subjects with ferromagnetic materials in the head
  7. * Subjects with a TENS unit

Contacts and Locations

Study Contact

Imran Quraishi, MD
CONTACT
(203) 785-3865
imran.quraishi@yale.edu

Principal Investigator

Imran Quraishi, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Imran Quraishi, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-24
Study Completion Date2026-02

Study Record Updates

Study Start Date2023-06-24
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Seizures