Focused Ultrasound for Binge Eating Disorder

N/A

Recruiting

Research Sponsored by Ali Rezai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Males and non-pregnant females, 22 - 65 years of age.

* Participant meets DSM-5 criteria for moderate to extreme BED.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 7, day 30, day 60, day 90; comparisons will be made relative to baseline, pre-lifu.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and tolerability of using LIFU for neuromodulation in patients with Binge Eating Disorder.

Who is the study for?

This trial is for men and women aged 22-60 who have moderate to extreme Binge Eating Disorder (BED) as defined by DSM-5. Participants must weigh less than or equal to 450 pounds, have a shoulder width of ≤65 inches to fit in an MRI machine, and their neuromodulation targets must be visible on MRI.

What is being tested?

The study tests the safety and tolerability of Low Intensity Focused Ultrasound (LIFU) for neuromodulation in patients with BED. It's an early-stage, single-center trial where all participants receive the same treatment without a comparison group.

What are the potential side effects?

As this is an early feasibility study primarily focused on safety and tolerability, specific side effects are not detailed but may include discomfort at the site of ultrasound application or temporary changes in mood or eating behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 7, day 30, day 60, day 90; comparisons will be made relative to baseline, pre-lifu.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 7, day 30, day 60, day 90; comparisons will be made relative to baseline, pre-lifu.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 7, day 30, day 60, day 90; comparisons will be made relative to baseline, pre-lifu. for reporting.