Trial Search Results

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Casey H. Halpern

Collaborator: NeuroPace

Stanford Investigator(s):

Intervention(s):

  • Device: responsive neurostimulation

Phase:

N/A

Eligibility


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 - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Vyvian Ngo
650-498-0817
Recruiting