Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study. Issue 6 (27th July 2020)

• Record Type: Journal Article
• Authors: Wu, Hemmings; Adler, Sarah; Azagury, Dan E; Bohon, Cara; Safer, Debra L; Barbosa, Daniel A N; Bhati, Mahendra T; Williams, Nolan R; Dunn, Laura B; Tass, Peter A; Knutson, Brian D; Yutsis, Maya; Fraser, Ayesha; Cunningham, Tricia; Richardson, Kara; Skarpaas, Tara L; Tcheng, Thomas K; Morrell, Martha J; Roberts, Laura Weiss; Malenka, Robert C; Lock, James D; Halpern, Casey H
• Is Part Of: Neurosurgery. Volume 87:Issue 6(2020)
• Page Start: 1277
• Page End: 1288
• Publication Date: 2020-07-27
• Subjects: Responsive neurostimulation -- DBS -- Deep brain stimulation -- Nucleus accumbens -- Loss of control -- Eating disorders -- Binge -- Obesity; Nervous system -- Surgery -- Periodicals; 617.48005
• DOI: 10.1093/neuros/nyaa300
• Languages: English
• ISSNs: 0148-396X

Abstract

Abstract: BACKGROUND: Loss 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. OBJECTIVE: To assess feasibility, safety, and nonfutility of brain-responsive neurostimulation for LOC eating in treatment-refractory obesity. METHODS: This 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/m 2 . 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 OUTCOMES: Safety/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. DISCUSSION: This study is the first to use brain-responsive neurostimulation for obesity; this approach represents a paradigm shift for intractable mental health disorders.