Noninvasive Targeted Neuromodulation for Treatment of Food Addiction
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in body weight (%) from baseline week 0 to week 16
研究概览
简要总结
This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •Body mass index more than or equal to 30 kg/m^2 or more than or equal to 25 kg/m^2 with the presence of at least one of the following weight-related comorbidities: hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.
排除标准
- •Lifetime history of a serious suicide attempt
- •MRI intolerance or contraindication
- •Pregnant or breast feeding
- •Diabetic (HbA1c more than 48 mmol/mol or 6.5%)
- •A self-reported change in body weight more than 10 lbs within 60 days before screening
- •Clinically inappropriate for participation in the study as determined by the study team
结局指标
主要结局
Change in body weight (%) from baseline week 0 to week 16
时间窗: The body weight will be taken prior to each intervention (once per week)
The body weight will be quantified with respect to baseline (100%), taken prior to the first intervention.
Number of participants who achieved body weight reduction >= 5%
时间窗: Assessment at week 16
Proportion of subjects who have lost at least 5% of their weight at week 16 relative to the baseline week 0.
Food Cravings Questionnaire-State
时间窗: During and immediately after each weekly intervention
This 15-item questionnaire measures immediate level of food craving, each item ranging from 1 (strongly disagree) to 5 (strongly agree). Higher total scores indicate stronger desire to eat.
Hamilton Depression Rating Scale, 17 item
时间窗: For up to 16 weeks
This 17-item questionnaire measures the severity of depression. Scores range between 0 (least severe) to 52 (most severe).
次要结局
未报告次要终点
研究者
Jan Kubanek
Assistant Professor
University of Utah