Low Intensity Focused Ultrasound for Binge Eating Disorder

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 orcochlear implants), shrapnel fragments, permanent make-up or small metal fragmentsin the eye that welders and other metal workers may have, or if candidates areuncomfortable in small spaces (have claustrophobia).

• Participants with more than 30% of the skull area traversed by the sonicationpathway 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 12months (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 anactive treatment arm.

• Use of any medications that, in the opinion of the Investigator, may put theparticipant at higher risk for AEs, or impair the participant's ability to performcomplete study procedures.

• Participant is considered to be a poor surgical or study candidate, which mayinclude, but is not limited to the following: any medical, social, or psychologicalproblem that could complicate the required procedures and evaluations of the studyin the judgment of the investigator.

• Participant is pregnant/lactating or planning to be pregnant.