Responsive Neurostimulation For Loss Of Control Eating
The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
Conditions:
🦠 Loss of Control Eating 🦠 Obesity, Morbid
🗓️ Study Start (Actual) 10 April 2019
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 1 January 2025
👥 Enrollment (Estimated) 6
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Stanford, California, United States
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * BMI 40-60 kg/m2
    • * Failure of at least one weight loss medication
    • * Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
    • * Significant Loss of Control over eating
    • * Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
    • * Premenopausal women must agree to use acceptable methods of birth control.
    • * Participants provide voluntary, decisionally capable, and appropriately informed consent.
    • * Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
    • * Participant has no immediate plan for relocation beyond 6 hours of the study site.
    • * Proficiency with the English language.

    Exclusion Criteria:

    • * Subject has an implanted medical device that delivers electrical energy to the brain.
    • * Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
    • * Subject is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
    • * Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
    • * Inability to provide informed consent to treatment.
Ages Eligible for Study: 22 Years to 65 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 14 February 2019
  • First Submitted that Met QC Criteria 6 March 2019
  • First Posted 11 March 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 July 2023
  • Last Update Posted 28 July 2023
  • Last Verified July 2023