NCT06485687进行中（未招募）不适用
Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Binge Eating Disorder (BED)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ali Rezai
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
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)
详细描述
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for BED
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: [baseline and day 7 and 90 after study procedure
All adverse events that are related to LIFU procedure will be assessed
次要结局
- 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.)
研究者
研究点 (2)
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