RECRUITING

Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial

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Conditions

Drug Resistant Epilepsy

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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

The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.

Official Title

Low Intensity Focused Ultrasound Treatment for Epilepsy: A Pilot Trial

Quick Facts

Study Start:2019-02-07
Study Completion:2025-11-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03868293

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects at least eighteen (18) years of age
  2. * Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.
  3. * Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency
  4. * Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.
  1. * Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
  2. * Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
  3. * Subjects with ferromagnetic materials in the head
  4. * Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
  5. * Subjects who have primary generalized epilepsy or non-epileptic seizures
  6. * Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study
  7. * Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
  8. * Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
  9. * Subjects with current brain tumors or an intracranial vascular lesion
  10. * Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
  11. * Subjects with holes in the treatment area of the skull from trauma or prior surgery
  12. * Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.

Contacts and Locations

Study Contact

Ellen J Bubrick, MD
CONTACT
617-732-7432
ebubrick@bwh.harvard.edu
Janet S Orozco, BS
CONTACT
781-382-8065
jorozco1@bwh.harvard.edu

Principal Investigator

Ellen J Bubrick, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Ellen J Bubrick, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Date2019-02-07
Study Completion Date2025-11-09

Study Record Updates

Study Start Date2019-02-07
Study Completion Date2025-11-09

Terms related to this study

Additional Relevant MeSH Terms

  • Drug Resistant Epilepsy