NCT05609604终止不适用
Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Body Weight
研究概览
简要总结
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
详细描述
- To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS
- To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR)
- To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS.
- To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 to 80 years of age
- •Body mass index > 30 kg/m2
排除标准
- •Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit
- •Pregnancy or premenopausal women who are trying to be pregnant
- •Patients who are incompetent to give consent
- •Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
- •Have taken any of the following medications within the past 3 months:
- •phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion
- •Any contraindication to receive transcranial direct current stimulation (tDCS):
- •Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
- •Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
- •Prior neurosurgical procedure or radiation.
- •Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
- •Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.
结局指标
主要结局
Change in Body Weight
时间窗: 5 weeks
change in body weight in Kg measured from baseline at 5 weeks
次要结局
未报告次要终点
研究者
Paresh Dandona
SUNY Distinguished Professor
University at Buffalo
研究点 (2)
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