TERMINATED

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.

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 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording. The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region . 2-5 sites in Europe Up to 10 sites in US

Official Title

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.

Quick Facts

Study Start:2021-04-21
Study Completion:2025-08-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04526418

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Michael Gelfand
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of California
Los Angeles, California, 90095
United States
University of South Florida (USF) Neurology Department
Tampa, Florida, 33606
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Hackensack Meridian Health
Neptune City, New Jersey, 07753
United States
Northwell Health Department of Neurosurgery
Great Neck, New York, 11021
United States
Cleveland Clinic, Neurological Institute
Cleveland, Ohio, 44195
United States
University of Pennsylvenia
Philadelphia, Pennsylvania, 19104
United States
UT Health Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: UNEEG Medical A/S

  • Michael Gelfand, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2021-04-21
Study Completion Date2025-08-29

Study Record Updates

Study Start Date2021-04-21
Study Completion Date2025-08-29

Terms related to this study

Keywords Provided by Researchers

  • Ultra Long-Term Recording of Patients with Epilepsy

Additional Relevant MeSH Terms

  • Epilepsy