Low Intensity Focused Ultrasound for Binge Eating Disorder

Launched by ALI REZAI · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of Low Intensity Focused Ultrasound (LIFU) as a potential new treatment for Binge Eating Disorder (BED). The aim is to see if this method is safe and tolerable for people who struggle with this condition. BED is characterized by frequently eating large amounts of food and feeling a lack of control during these episodes. The study is currently recruiting participants aged 22 to 65 who meet specific criteria for moderate to severe BED and have a weight of 450 pounds or less.

To participate, individuals must be able to undergo MRI scans, which help researchers see the brain areas being targeted for treatment. However, there are several important exclusions, such as having certain medical implants or mental health conditions like schizophrenia or bipolar disorder. Participants will receive information about the study and will need to give their consent before joining. Throughout the trial, they can expect to undergo assessments and monitoring to ensure their safety. Overall, this study aims to investigate a new potential way to help those affected by binge eating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and non-pregnant females, 22 - 65 years of age.
• • Participant meets DSM-5 criteria for moderate to extreme BED.
• • Weight ≤450lb to accommodate in MRI.
• • Shoulder width of ≤65 inches to accommodate in MRI.
• • The neuromodulation targets are visible on MRI for target selection.
• • Participant is able and willing to give informed consent.
• Exclusion Criteria:
• • Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
• • Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
• • Participants with known untreated or unstable cardiac status or hypertension
• • Evidence of substance (alcohol or other drug) use disorder during the previous 12 months (assessed via SCID-5).
• • Past or present diagnosis of schizophrenia, psychotic disorder or bipolar disorder (assessed via SCID-5)
• • Participant who is currently participating in another clinical investigation with an active treatment arm.
• • Use of any medications that, in the opinion of the Investigator, may put the participant at higher risk for AEs, or impair the participant's ability to perform complete study procedures.
• • Participant is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
• • Participant is pregnant/lactating or planning to be pregnant.