Low Intensity Focused Ultrasound for Binge Eating Disorder

Ali Rezai

Status

Enrolling

Conditions

Binge-Eating Disorder

Treatments

Device: LIFU Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06485687

RNI_NMD_BED01

Details and patient eligibility

About

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)

Full description

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

Enrollment

15 estimated patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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.