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🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2024-08-27)

Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.

🟢 Recruiting Protocol / Phase N/A ⚙️ Medical Device Protocol Sponsor: Epitel, Inc.

🩺 Protocol Summary

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Primary Research Facility: University of South Florida (Tampa, Florida)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

📍 Primary Site Map

Site: University of South Florida — Tampa, Florida

📍 All Participating Trial Locations (2 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of South FloridaTampa, Florida • Contact: (813) 250-2323
2. Medical University of South CarolinaCharleston, South Carolina

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06027749 • Last Synced: 2024-08-27
View on ClinicalTrials.gov ↗
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