• Hemmings Wu, Sarah Adler, Dan E Azagury, Cara Bohon, Debra L Safer, Daniel A N Barbosa, Mahendra T Bhati, Nolan R Williams, Laura B Dunn, Peter A Tass, Brian D Knutson, Maya Yutsis, Ayesha Fraser, Tricia Cunningham, Kara Richardson, Tara L Skarpaas, Thomas K Tcheng, Martha J Morrell, Laura Weiss Roberts, Robert C Malenka, James D Lock, and Casey H Halpern.
• Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.
• Neurosurgery. 2020 Nov 16; 87 (6): 127712881277-1288.

BackgroundLoss of control (LOC) is a pervasive feature of binge eating, which contributes significantly to the growing epidemic of obesity; approximately 80 million US adults are obese. Brain-responsive neurostimulation guided by the delta band was previously found to block binge-eating behavior in mice. Following novel preclinical work and a human case study demonstrating an association between the delta band and reward anticipation, the US Food and Drug Administration approved an Investigational Device Exemption for a first-in-human study.ObjectiveTo assess feasibility, safety, and nonfutility of brain-responsive neurostimulation for LOC eating in treatment-refractory obesity.MethodsThis is a single-site, early feasibility study with a randomized, single-blinded, staggered-onset design. Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc). Eligible participants must have treatment-refractory obesity with body mass index ≥ 45 kg/m2. Electrophysiological signals of LOC will be characterized using real-time recording capabilities coupled with synchronized video monitoring. Effects on other eating disorder pathology, mood, neuropsychological profile, metabolic syndrome, and nutrition will also be assessed.Expected OutcomesSafety/feasibility of brain-responsive neurostimulation of the nucleus accumbens will be examined. The primary success criterion is a decrease of ≥1 LOC eating episode/week based on a 28-d average in ≥50% of subjects after 6 mo of responsive neurostimulation.DiscussionThis study is the first to use brain-responsive neurostimulation for obesity; this approach represents a paradigm shift for intractable mental health disorders.Copyright © 2020 by the Congress of Neurological Surgeons.

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