Low Intensity Focused Ultrasound for Binge Eating Disorder | NCT06485687

Studies
Low Intensity Focused Ultrasound for Binge Eating Disorder

NCT06485687

Sponsor

Ali Rezai

Status

Active, not recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Binge-Eating Disorder

Interventions

LIFU Neuromodulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 18, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
LIFU Neuromodulation	Experimental		Device: LIFU Neuromodulation

Name	Type	Description	Arm Group Labels	Other Names
LIFU Neuromodulation	Device	Subjects will undergo a single LIFU of the target brain region	LIFU Neuromodulation

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders