Low Intensity Focused Ultrasound for Binge Eating Disorder

NCT06485687 | Active Not Recruiting DMC FDA Device

• 1 other identifier: RNI_NMD_BED01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with Binge Eating Disorder (BED)

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events

  All adverse events that are related to LIFU procedure will be assessed

  [baseline and day 7 and 90 after study procedure

Secondary Outcomes (1)

• Effect of LIFU on Food craving

  Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.

Study Arms (1)

LIFU Neuromodulation

EXPERIMENTAL

Device: LIFU Neuromodulation

Interventions

LIFU Neuromodulation DEVICE

Subjects will undergo a single LIFU of the target brain region

LIFU Neuromodulation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali Rezai: lead

Study Sites (1)

West Virginia University: Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ali Rezai

  WVU Rockefeller Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director RNI

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)