Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia.
The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa criteria
- •Body Mass Index (BMI) < 17kg/m2
- •Conventional treatment failure over the last 12 months
- •Refusal or no indication of artificial nutrition
排除标准
- •Artificial nutrition
- •Other chronic diseases
- •drug use (except tobacco)
- •pregnancy
- •Edinburgh score < 14
结局指标
主要结局
Body Mass Index (BMI)
时间窗: weeks 8
Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m\^2
次要结局
- Eating Disorder Inventory (EDI)(weeks 8)
- State-Trait Anxiety Inventory (STAI)(weeks 8)
- Dutch Eating Behavior Questionnaire (DEBQ)(weeks 8)
- Beck Depression Inventory (BDI)(weeks 8)