Low Intensity Focused Ultrasound for Binge Eating Disorder

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for BED

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.