Low Intensity Focused Ultrasound for Binge Eating Disorder

NCT ID: NCT06485687

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2027-12-31

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)

Detailed Description

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

Conditions

Binge-Eating Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIFU Neuromodulation

Group Type: EXPERIMENTAL

LIFU Neuromodulation

Intervention Type: DEVICE

Subjects will undergo a single LIFU of the target brain region

Interventions

LIFU Neuromodulation

Subjects will undergo a single LIFU of the target brain region

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ali Rezai

OTHER

Sponsor Role: lead

Responsible Party

Ali Rezai

Director RNI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ali Rezai

Role: PRINCIPAL_INVESTIGATOR

WVU Rockefeller Neuroscience Institute

Locations

West Virginia University: Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Padma Tirumalai

Role: CONTACT

Phone: 3042760500

Email: ptirumalai@hsc.wvu.edu

Victor Finomore

Role: CONTACT

Phone: 304-255-0055

Email: victor.finomore@hsc.wvu.edu

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

RNI_NMD_BED01

Identifier Type: -

Identifier Source: org_study_id