Neuroliten MVP System Clinical Observation Study
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.
Conditions:
🦠 Epilepsy
🗓️ Study Start (Actual) 31 October 2022
🗓️ Primary Completion (Estimated) March 2024
✅ Study Completion (Estimated) April 2024
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Loveland, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
    • 2. Male and female subjects ages 18 to 75, inclusive.
    • 3. Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
    • 4. Diagnosed with intractable or refractory epilepsy.
    • 5. Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study.
    • 6. Have implanted vagus nerve stimulation (VNS).
    • 7. Have the ability to understand the requirements of the study and are willing to comply with all study requirements.
    • 8. Must have a working Apple iPhone.

    Exclusion Criteria:

    • 1. Women who are either pregnant or breastfeeding.
    • 2. Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
    • 3. Requires the use of a ventilator.
    • 4. Requires the use of supplemental oxygen.
    • 5. Uses a pacemaker or other electronic neurostimulator, except the VNS.
    • 6. Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 23 August 2022
  • First Submitted that Met QC Criteria 25 August 2022
  • First Posted 30 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 September 2023
  • Last Update Posted 14 September 2023
  • Last Verified September 2023