responsive neurostimulation for Binge Eating Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Binge Eating Disorder+1 Moreresponsive neurostimulation - Device
Eligibility
22 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is to assess the function and safety of a device, with secondary objectives including feasibility.

Eligible Conditions
  • Binge Eating Disorder
  • Morbid Obesity

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 5 years

5 years
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]

Trial Safety

Trial Design

1 Treatment Group

Responsive Neurostimulation
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: responsive neurostimulation · No Placebo Group · N/A

Responsive Neurostimulation
Device
Experimental Group · 1 Intervention: responsive neurostimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Casey H. HalpernLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Casey HalpernLead Sponsor
NeuroPaceIndustry Sponsor
10 Previous Clinical Trials
1,489 Total Patients Enrolled

Eligibility Criteria

Age 22 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subject is able to attend all scheduled clinic appointments by themselves or with a caregiver.
The subject is able to comply with all the testing and follow-up requirements defined by the study protocol.
A BMI of between 40 and 60 kg/m2 is considered obese.
may be due to genetic causes It is possible that the failure of at least one weight loss medication is due to genetic causes
can be a hallmark of an Eating Disorder If someone experiences a significant loss of control over their eating habits, it is often a hallmark sign of an eating disorder
Women who are premenopausal must agree to use acceptable methods of birth control.
People providing their consent voluntarily, of their own accord, and while knowing all the facts, is considered the best possible situation.
The participant doesn't have any immediate plans to relocate outside of a six-hour radius of the study site.
The ability to use English effectively.