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)
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for BED
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subjects will undergo a single LIFU of the target brain region
West Virginia University: Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to LIFU procedure will be assessed
Time frame: [baseline and day 7 and 90 after study procedure
Effect of LIFU on Food craving
Visual Analog scale and food diary
Time frame: Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.
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