Clinical trial NCT06485687: Low Intensity Focused Ultrasound for Binge Eating Disorder
Official title: Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Binge Eating Disorder (BED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Occurrence of Treatment Emergent Adverse Events
timeFrame: [baseline and day 7 and 90 after study procedure
Secondary outcomes:
measure: Effect of LIFU on Food craving
timeFrame: Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University: Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: WVU Rockefeller Neuroscience Institute
name: Ali Rezai
role: PRINCIPAL_INVESTIGATOR
References: