Using low intensity focused ultrasound to treat binge eating disorder

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Binge Eating Disorder (BED)

This study is testing if low intensity focused ultrasound can be a safe and helpful treatment for people with binge eating disorder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: West Virginia University (other)
• Locations: 1 site (Morgantown, West Virginia)
• Trial ID: NCT06485687 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of low intensity focused ultrasound (LIFU) as a neuromodulatory treatment for patients with binge eating disorder (BED). It is a single-center, single-arm early feasibility study that aims to establish whether LIFU can be a viable adjunct treatment option. Participants will undergo LIFU treatment while their safety and response are monitored. The study focuses on individuals who meet specific criteria for moderate to extreme BED.

Who should consider this trial

Good fit: Ideal candidates are males and non-pregnant females aged 22 to 65 who meet the DSM-5 criteria for moderate to extreme binge eating disorder.

Not a fit: Patients with contraindications for MRI or significant scalp conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, non-invasive option for managing binge eating disorder.

How similar studies have performed: While this approach is novel, similar neuromodulatory techniques have shown promise in other conditions, suggesting potential for success.

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.

Where this trial is running

Morgantown, West Virginia

• West Virginia University: Rockefeller Neuroscience Institute — Morgantown, West Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Ali Rezai — WVU Rockefeller Neuroscience Institute
• Study coordinator: Padma Tirumalai

Conditions: Binge-Eating Disorder