Responsive Neurostimulation for Binge Eating Disorder
(DBSLOC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Casey H. Halpern
Must be taking: GLP-1 agonists
Must not be taking: Appetite suppressants
Disqualifiers: Neurological disorders, Severe depression, Drug abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
Will I have to stop taking my current medications?
The trial requires that any medical conditions and related therapies or medications be stable for the past 6 months and remain stable during the study. This means you should not change your current medications if they are related to a stable medical condition.
What data supports the effectiveness of the treatment Responsive Neurostimulation for Binge Eating Disorder?
A pilot study using responsive deep brain stimulation (DBS) in two patients with binge eating disorder showed improved self-control of food intake and weight loss over 6 months, suggesting early support for this approach. However, more research with larger sample sizes is needed to confirm these findings.
12345Is responsive neurostimulation safe for humans?
Responsive neurostimulation, including deep brain stimulation (DBS), has been used in small studies for conditions like binge eating disorder and has shown some promise in improving self-control and reducing cravings. However, more research with larger groups is needed to fully understand its safety and effectiveness.
14567How does responsive neurostimulation differ from other treatments for binge eating disorder?
Responsive neurostimulation is unique because it uses deep brain stimulation (DBS) to target specific brain activity patterns associated with food cravings, helping to improve self-control over eating. Unlike other treatments, it delivers stimulation only when abnormal brain activity is detected, potentially offering a more precise and effective approach to managing binge eating disorder.
14789Eligibility Criteria
This trial is for adults with severe obesity (BMI 40-60) who've tried at least one weight loss medication without success. They must be able to attend clinic visits, follow study rules, and premenopausal women should use birth control. It's not for those with brain implants or pacemakers, or who can't fit in a CT scanner.Inclusion Criteria
Proficiency with the English language.
I understand the study and agree to participate.
Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
+7 more
Exclusion Criteria
You have a medical device in your brain that uses electrical energy.
You have a device in your body like a pacemaker, defibrillator, or neurostimulator.
Subject is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical Treatment
Participants undergo surgery to receive the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation
1-2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The trial is testing responsive neurostimulation, a device that may help control binge eating by sending electrical impulses to the brain. The focus is on how well the device works and its safety.
1Treatment groups
Experimental Treatment
Group I: Responsive NeurostimulationExperimental Treatment1 Intervention
Surgical arm. Patients expected to receive treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Casey H. HalpernLead Sponsor
Casey HalpernLead Sponsor
University of PennsylvaniaLead Sponsor
NeuroPaceIndustry Sponsor
References
Pilot study of responsive nucleus accumbens deep brain stimulation for loss-of-control eating. [2022]Cravings that precede loss of control (LOC) over food consumption present an opportunity for intervention in patients with the binge eating disorder (BED). In this pilot study, we used responsive deep brain stimulation (DBS) to record nucleus accumbens (NAc) electrophysiology during food cravings preceding LOC eating in two patients with BED and severe obesity (trial registration no. NCT03868670). Increased NAc low-frequency oscillations, prominent during food cravings, were used to guide DBS delivery. Over 6 months, we observed improved self-control of food intake and weight loss. These findings provide early support for restoring inhibitory control with electrophysiologically-guided NAc DBS. Further work with increased sample sizes is required to determine the scalability of this approach.
Increases in frontostriatal connectivity are associated with response to dorsomedial repetitive transcranial magnetic stimulation in refractory binge/purge behaviors. [2019]Conventional treatments for eating disorders are associated with poor response rates and frequent relapse. Novel treatments are needed, in combination with markers to characterize and predict treatment response. Here, resting-state functional magnetic resonance imaging (rs-fMRI) was used to identify predictors and correlates of response to repetitive transcranial magnetic stimulation (rTMS) of the dorsomedial prefrontal cortex (dmPFC) at 10 Hz for eating disorders with refractory binge/purge symptomatology.
Targeting Neural Endophenotypes of Eating Disorders with Non-invasive Brain Stimulation. [2020]The term "eating disorders" (ED) encompasses a wide variety of disordered eating and compensatory behaviors, and so the term is associated with considerable clinical and phenotypic heterogeneity. This heterogeneity makes optimizing treatment techniques difficult. One class of treatments is non-invasive brain stimulation (NIBS). NIBS, including repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are accessible forms of neuromodulation that alter the cortical excitability of a target brain region. It is crucial for NIBS to be successful that the target is well selected for the patient population in question. Targets may best be selected by stepping back from conventional DSM-5 diagnostic criteria to identify neural substrates of more basic phenotypes, including behavior related to rewards and punishment, cognitive control, and social processes. These phenotypic dimensions have been recently laid out by the Research Domain Criteria (RDoC) initiative. Consequently, this review is intended to identify potential dimensions as outlined by the RDoC and the underlying behavioral and neurobiological targets associated with ED. This review will also identify candidate targets for NIBS based on these dimensions and review the available literature on rTMS and tDCS in ED. This review systematically reviews abnormal neural circuitry in ED within the RDoC framework, and also systematically reviews the available literature investigating NIBS as a treatment for ED.
The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. [2019]Binge eating disorder is a new category in DSM-5 and highly associated with higher body mass index. The neural mechanisms that underlie binge eating are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar: for example, both are reported to be associated with increased neural activity in the orbitofrontal and anterior cingulate cortex, and a diminished regulatory influence from lateral prefrontal circuits. Several studies have begun to assess the potential benefits of brain stimulation in reducing craving and addictive behaviors. Data from a study of a one-off session of transcranial magnetic stimulation in healthy women identified as strong cravers and of individuals with bulimic-type eating disorders, reported a reduction in food craving and binge eating episodes. This provides support for a more extensive investigation of the potential therapeutic benefits of transcranial magnetic stimulation. Lastly, brain imaging studies and a dimensional approach, will improve understanding of the neural correlates of the disorders and of the mode of action of transcranial magnetic stimulation.
Neuromodulation and Eating Disorders. [2023]We review recent evidence on the use of neuromodulation for treating eating disorders (EDs), including anorexia nervosa, bulimia nervosa and binge eating disorder. We evaluate studies on (a) modern non-invasive methods of brain stimulation, such as transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), (b) electroconvulsive therapy (ECT) and (c) more invasive techniques, including deep brain stimulation (DBS).
Unanticipated Rapid Remission of Refractory Bulimia Nervosa, during High-Dose Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex: A Case Report. [2021]A woman with severe, refractory bulimia nervosa (BN) underwent treatment for comorbid depression using repetitive transcranial magnetic stimulation (rTMS) of the dorsomedial prefrontal cortex (DMPFC) using a novel technique. Unexpectedly, she showed a rapid, dramatic remission from BN. For 5 months pre-treatment, she had reported two 5-h binge-purge episodes per day. After rTMS session 2 the episodes stopped entirely for 1 week; after session 10 there were no further recurrences. Depression scores improved more gradually to remission at session 10. Full remission from depression and binge-eating/purging episodes was sustained more than 2 months after treatment completion. In neuroimaging studies, the DMPFC is important in impulse control, and is underactive in BN. DMPFC-rTMS may have enhanced the patient's ability to deploy previously acquired strategies to avoid binge-eating and purging via a reduction in her impulsivity. A larger sham-controlled trial of DMPFC-rTMS for binge-eating and purging behavior may be warranted.
Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. [2022]To investigate the effect of transcranial direct current stimulation (tDCS) on food craving, intake, binge eating desire, and binge eating frequency in individuals with binge eating disorder (BED).
Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. [2018]To describe the state of the human research literature pertaining to the use of non-invasive brain stimulation (NIBS) procedures for modulating food cravings, food consumption, and treating disorders of eating (i.e., obesity, bulimia nervosa, and anorexia nervosa).
Local accumbens in vivo imaging during deep brain stimulation reveals a strategy-dependent amelioration of hedonic feeding. [2022]Impulsive overeating is a common, disabling feature of eating disorders. Both continuous deep brain stimulation (DBS) and responsive DBS, which limits current delivery to pathological brain states, have emerged as potential therapies. We used in vivo fiber photometry in wild-type, Drd1-cre, and A2a-cre mice to 1) assay subtype-specific medium spiny neuron (MSN) activity of the nucleus accumbens (NAc) during hedonic feeding of high-fat food, and 2) examine DBS strategy-specific effects on NAc activity. D1, but not D2, NAc GCaMP activity increased immediately prior to high-fat food approach. Responsive DBS triggered a GCaMP surge throughout the stimulation period and durably reduced high-fat intake. However, with continuous DBS, this surge decayed, and high-fat intake reemerged. Our results argue for a stimulation strategy-dependent modulation of D1 MSNs with a more sustained decrease in consumption with responsive DBS. This study illustrates the important role in vivo imaging can play in understanding effects of such novel therapies.