Dataset Information

Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.

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/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 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.

SUBMITTER: Wu H

PROVIDER: S-EPMC8599841 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.

Wu Hemmings H Adler Sarah S Azagury Dan E DE Bohon Cara C Safer Debra L DL Barbosa Daniel A N DAN Bhati Mahendra T MT Williams Nolan R NR Dunn Laura B LB Tass Peter A PA Knutson Brian D BD Yutsis Maya M Fraser Ayesha A Cunningham Tricia T Richardson Kara K Skarpaas Tara L TL Tcheng Thomas K TK Morrell Martha J MJ Roberts Laura Weiss LW Malenka Robert C RC Lock James D JD Halpern Casey H CH

Neurosurgery 20201101 6

<h4>Background</h4>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 Inve ...[more]

PMID: 32717033

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Project description:ObjectiveBrain-responsive neurostimulation (RNS System, NeuroPace) is used to treat medically refractory focal epilepsy and also provides long-term ambulatory neurophysiologic data. We sought to determine whether these data could predict the clinical response to antiseizure drugs (ASDs).MethodsFirst, newly added medications were identified in RNS System patients followed at a single epilepsy center. Daily detection rates including "episode starts" (predominantly interictal activity) and "long episodes" (often electrographic seizures) were compared before and after ASD initiation. Efficacy was determined from documentation of clinical improvement and medication retention. Next, the analysis was repeated on an independent sample of patients from a multicenter long-term treatment trial, using an efficacy measure of ≥50% reduction in diary-recorded seizure frequency after 3 months.ResultsIn the single center cohort, long episodes, but not episode starts, had a significantly greater reduction in the first week for clinically efficacious compared to inefficacious medications. In this cohort, having no long episodes in the first week was highly predictive of ASD efficacy. In the multicenter cohort, both long episodes and episode starts had a significantly greater reduction for effective medications starting in the first 1-2 weeks. In this larger dataset, a ≥50% decrease in episode starts was 90% specific for efficacy with a positive predictive value (PPV) of 67%, and a ≥84% decrease in long episodes was 80% specific with a PPV of 48%. Conversely, a <25% decrease in long episodes (including any increase) or a <20% decrease in episode starts had a predictive value for inefficacy of >80%.SignificanceIn RNS System patients with stable detection settings, when new ASDs are started, detection rates within the first 1-2 weeks may provide an early, objective indication of efficacy. These data could be used to identify responses to medication trials early to allow more rapid medication adjustments than conventionally possible.

Project description:ObjectiveThe RNS System is a direct brain-responsive neurostimulation system that is US Food and Drug Administration-approved for adults with medically intractable focal onset seizures based on safety and effectiveness data from controlled clinical trials. The purpose of this study was to retrospectively evaluate the real-world safety and effectiveness of the RNS System.MethodsEight comprehensive epilepsy centers conducted a chart review of patients treated with the RNS System for at least 1 year, in accordance with the indication for use. Data included device-related serious adverse events and the median percent change in disabling seizure frequency from baseline at years 1, 2, and 3 of treatment and at the most recent follow-up.ResultsOne hundred fifty patients met the criteria for analysis. The median reduction in seizures was 67% (interquartile range [IQR] = 33%-93%, n = 149) at 1 year, 75% (IQR = 50%-94%, n = 93) at 2 years, 82% (IQR = 50%-96%, n = 38) at ≥3 years, and 74% (IQR = 50%-96%, n = 150) at last follow-up (mean = 2.3 years). Thirty-five percent of patients had a ≥90% seizure frequency reduction, and 18% of patients reported being clinically seizure-free at last follow-up. Seizure frequency reductions were similar regardless of patient age, age at epilepsy onset, duration of epilepsy, seizure onset in mesial temporal or neocortical foci, magnetic resonance imaging findings, prior intracranial monitoring, prior epilepsy surgery, or prior vagus nerve stimulation treatment. The infection rate per procedure was 2.9% (6/150 patients); five of the six patients had an implant site infection, and one had osteomyelitis. Lead revisions were required in 2.7% (4/150), and 2.0% (3/150) of patients had a subdural hemorrhage, none of which had long-lasting neurological consequences.SignificanceIn this real-world experience, safety was similar and clinical seizure outcomes exceeded those of the prospective clinical trials, corroborating effectiveness of this therapy and suggesting that clinical experience has informed more effective programming.

Dataset Information

Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.

Background

Objective

Methods

Expected outcomes

Discussion

Publications

Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.

Similar Datasets

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