Low Intensity Focused Ultrasound for Binge Eating Disorder

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Device: LIFU Neuromodulation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University: Rockefeller Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIFU Neuromodulation	Device: LIFU Neuromodulation; Subjects will undergo a single LIFU of the target brain region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of LIFU on Food craving	Visual Analog scale and food diary	Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.

Collaborators and Investigators

• Sponsor: Ali Rezai
• Investigators: Principal Investigator: Ali Rezai, WVU Rockefeller Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: RNI_NMD_BED01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes