ACTIVE_NOT_RECRUITING

Low Intensity Focused Ultrasound for Binge Eating Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2024-10-31

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06485687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Ali Rezai

PRINCIPAL_INVESTIGATOR

WVU Rockefeller Neuroscience Institute

Study Locations (Sites)

West Virginia University: Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Ali Rezai

Ali Rezai, PRINCIPAL_INVESTIGATOR, WVU Rockefeller Neuroscience Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Binge-Eating Disorder