FUS Neuromodulation for Binge Eating Disorder

A candidate will be eligible if they meet all the following criteria:

• Age 18-80 years at time of enrollment.
• Diagnosis of moderate to extreme binge eating disorder (BED) per DSM-5-TR criteria
• Participant is able and willing to give informed consent.
• Participant is willing to cooperate with the study requirements, including compliance with the regimen, completion of all study visits, and study assessments.
• Participants of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.
• Participant able to communicate sensations during the procedure.

A candidate will be excluded if they meet any of the following criteria:

• Unable to undergo MR-imaging or clinically significant MRI findings
• History of any clinically significant neurological disorder.
• Evidence of substance (alcohol or other drug) use disorder during the previous 12 months .
• Past or present diagnosis of psychotic disorder or bipolar disorder
• Currently taking opioid pain medications or positive drug screen for opiates.
• If participants are on medication for the treatment of binge eating disorder or obesity (they must be on a stable dose for at least one month and agree to not begin a medication until after their Week 12 visit.
• Subject has a lifetime history or current symptoms consistent with bulimia nervosa or anorexia nervosa .
• Have a recorded or self-reported change in body weight >11 lbs. within 3 months prior to screening
• Have a prior or planned surgical treatment for obesity (excluding lap-band if removed >6 months prior to screening or liposuction or abdominoplasty if performed >1 year prior to screening)
• Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening
• History of medically verified suicide attempt within the past year. Clinically significant suicide risk
• Participant who is currently participating in another clinical investigation with an active treatment arm.
• 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.