Responsive Neurostimulation for Binge Eating Disorder

(DBSLOC Trial)

Not currently recruiting at 1 trial location

Overseen By Casey Halpern, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device treatment called Responsive Neurostimulation to determine its effectiveness for people with binge eating disorder. The primary focus is to ensure the device operates safely and to assess its practicality. Suitable participants have experienced frequent overeating and have not succeeded with other weight loss treatments, such as medication, behavioral therapy, or surgeries. Participants should also have stable health conditions and be able to attend regular clinic visits. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for binge eating disorder.

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 prior data suggests that this device is safe for treating binge eating disorder?

Research has shown that a treatment called responsive neurostimulation has been safe in earlier studies. This treatment sends signals to the nucleus accumbens, a part of the brain that helps control eating. In past studies, patients managed their eating habits better without serious side effects. These studies examined the safety and practicality of the treatment for people with binge eating disorder and involved close monitoring of participants. So far, the treatment appears well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Responsive Neurostimulation is unique because it offers a novel approach to treating Binge Eating Disorder by directly interacting with the brain's electrical activity. Unlike traditional treatments like cognitive-behavioral therapy or medications that target neurotransmitters, Responsive Neurostimulation involves a surgical implant that monitors and responds to brain signals in real-time. This direct and dynamic intervention allows for precise modulation of brain activity associated with binge eating episodes, potentially leading to more immediate and effective results. Researchers are excited about this treatment because it represents a shift towards personalized, adaptive therapy, possibly reducing the frequency and intensity of binge eating episodes in patients who may not fully respond to standard treatments.

What evidence suggests that this device is effective for binge eating disorder?

Research has shown that a treatment called responsive neurostimulation, which participants in this trial will receive, might help people with binge eating disorder. In one small study, participants gained better control over their eating and lost weight over six months. Another study with two participants also found improved control over eating and weight. These early results suggest that this treatment could help reduce binge eating by boosting self-control. While more research is needed, the initial findings are promising for those dealing with binge eating disorder. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Responsive Neurostimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Responsive Neurostimulation Experimental Treatment 1 Intervention

Surgical arm. Patients expected to receive treatment.

Who Is Running the Clinical Trial?

Casey H. Halpern

Lead Sponsor

Trials

2

Recruited

10+

Casey Halpern

Lead Sponsor

Trials

1

Recruited

6+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

NeuroPace

Industry Sponsor

Trials

11

Recruited

1,500+

Published Research Related to This Trial

This study will investigate the efficacy of transcranial magnetic stimulation (TMS) in reducing binge eating episodes among 60 obese females with binge eating disorder, comparing results from 20 sessions of TMS to a sham treatment.

The research aims to provide insights into the neural mechanisms of binge eating disorder and assess whether TMS can lead to a significant reduction in binge eating episodes, with follow-up assessments planned 8 weeks after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. Maranhão, MF., Estella, NM., Cury, ME., et al.[2019]

This pilot study involved two patients with binge eating disorder (BED) and severe obesity, using responsive deep brain stimulation (DBS) to monitor brain activity during food cravings.

Over a 6-month period, the patients showed improved self-control over food intake and experienced weight loss, suggesting that targeting the nucleus accumbens (NAc) with DBS may help restore control over eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of responsive nucleus accumbens deep brain stimulation for loss-of-control eating. Shivacharan, RS., Rolle, CE., Barbosa, DAN., et al.[2022]

Responsive deep brain stimulation (DBS) effectively reduces impulsive overeating by triggering sustained activity in D1 medium spiny neurons in the nucleus accumbens, leading to a long-term decrease in high-fat food intake.

In contrast, continuous DBS resulted in a decay of this neuronal activity and a return to high-fat intake, highlighting the importance of stimulation strategy in managing overeating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local accumbens in vivo imaging during deep brain stimulation reveals a strategy-dependent amelioration of hedonic feeding. Wu, H., Kakusa, B., Neuner, S., et al.[2022]

A woman with severe bulimia nervosa experienced a rapid and complete remission of binge-purge episodes after undergoing repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex (DMPFC), with no episodes occurring after the 10th session.

The treatment also led to significant improvements in her depression, suggesting that DMPFC-rTMS may enhance impulse control, which is crucial for managing bulimia nervosa. Further research with larger trials is recommended to explore this treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unanticipated Rapid Remission of Refractory Bulimia Nervosa, during High-Dose Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex: A Case Report. Downar, J., Sankar, A., Giacobbe, P., et al.[2021]

In a study of 28 subjects with anorexia nervosa or bulimia nervosa, 16 participants showed a significant response to repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex, indicating its potential efficacy for treating binge/purge behaviors.

Resting-state functional MRI (rs-fMRI) revealed that treatment responders had distinct neural connectivity patterns at baseline, which changed positively during treatment, while nonresponders exhibited high baseline connectivity that worsened with rTMS, suggesting that rs-fMRI could help tailor future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increases in frontostriatal connectivity are associated with response to dorsomedial repetitive transcranial magnetic stimulation in refractory binge/purge behaviors. Dunlop, K., Woodside, B., Lam, E., et al.[2019]

Non-invasive brain stimulation (NIBS) techniques like rTMS and tDCS may offer promising treatment options for eating disorders (ED) by targeting specific neural substrates related to behaviors such as reward processing and cognitive control.

The review emphasizes the importance of selecting appropriate brain targets for NIBS based on the Research Domain Criteria (RDoC) framework, which could enhance treatment efficacy by focusing on the underlying neurobiological and behavioral dimensions of ED rather than just traditional diagnostic criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Neural Endophenotypes of Eating Disorders with Non-invasive Brain Stimulation. Dunlop, KA., Woodside, B., Downar, J.[2020]

Recent evidence suggests that neuromodulation techniques, particularly rTMS and DBS, show therapeutic potential and safety in treating severe cases of anorexia nervosa, although most studies are limited to small trials and case reports.

There is a need for high-quality clinical trials to explore various neuromodulation methods and their mechanisms of action across different eating disorder populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation and Eating Disorders. Gallop, L., Flynn, M., Campbell, IC., et al.[2023]

Non-invasive brain stimulation (NIBS), especially repetitive transcranial magnetic stimulation (rTMS), has been shown to effectively reduce food cravings in both single-session and multi-session formats, with more consistent results compared to transcranial direct current stimulation (tDCS).

While preliminary findings suggest potential benefits of NIBS for treating obesity and eating disorders, more research is needed to confirm these effects, particularly for conditions like bulimia and binge eating disorder, and caution is advised when considering NIBS for anorexia due to possible adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. Hall, PA., Vincent, CM., Burhan, AM.[2018]

Transcranial direct current stimulation (tDCS) significantly reduced cravings for various foods and decreased overall food intake by 11% and preferred food intake by 17.5% in individuals with binge eating disorder (BED), based on a study of 30 adults.

The study suggests that tDCS may enhance cognitive control and reduce the desire for food rewards, indicating its potential as a safe and noninvasive treatment option for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. Burgess, EE., Sylvester, MD., Morse, KE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8599841/

Brain-Responsive Neurostimulation for Loss of Control ... Moreover, this study is expected to provide proof-of-concept and feasibility data; in at least half of the participants, a decreased mean weekly ...

2. nature.com nature.com/articles/s41591-022-01941-w

Pilot study of responsive nucleus accumbens deep brain ... Over 6 months, we observed improved self-control of food intake and weight loss. These findings provide early support for restoring inhibitory ...

3. withpower.com withpower.com/trial/phase-obesity-morbid-3-2019-c1d98

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 ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05296915

Bulimia Nervosa and Binge Eating Disorder: Comparing ... This study aims to assess the effectiveness of new neurostimulation techniques in patients with eating disorders. The primary aim of our proposal is to test ...

5. mdpi.com mdpi.com/2072-6643/16/10/1521

The Effectiveness of Transcranial Direct Current ... tDCS proved effective in reducing food cravings, the desire to binge eat, the number of binging episodes, and food intake.

6. reporter.nih.gov reporter.nih.gov/project-details/11015853

Project Details - NIH RePORTER This UH3 study aims to examine the safety, feasibility, and preliminary efficacy of responsive neurostimulation of the NAc for LOC eating. Two subjects are ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03868670

Responsive Neurostimulation For Loss Of Control Eating This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity. What is the ...

8. researchgate.net researchgate.net/publication/359263886_Responsive_nucleus_accumbens_deep_brain_stimulation_restores_eating_control_in_severe_obesity

Responsive nucleus accumbens deep brain stimulation ... Here, we used responsive deep brain stimulation (DBS) to record NAc electrophysiology during food cravings preceding LOC eating in two patients with BED and ...