Binge-Eating Disorder
Conditions
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
Interventions
DEVICELIFU Neuromodulation
Subjects will undergo a single LIFU of the target brain region
Sponsors
Ali Rezai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events | [baseline and day 7 and 90 after study procedure | All adverse events that are related to LIFU procedure will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of LIFU on Food craving | Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU. | Visual Analog scale and food diary |
Countries
United States
Outcome results
None listed