Responsive Neurostimulation For Loss Of Control Eating
Trial ID or NCT#
NCT03868670
Status
RECRUITING
Purpose
The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
Official Title
Responsive Neurostimulation For Loss Of Control Eating
Eligibility Criteria
Ages Eligible for Study: 22 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Contact us to find out if this trial is right for you.
Contact
Vyvian Ngo
650-498-0817
View on ClinicalTrials.gov
