The Dorsomedial Prefrontal Cortex as a Target in Treatment-resistant Bulimia Nervosa and Anorexia Nervosa: Investigating Target Engagement, Dosing, Reliability and Duration of Effect Using rTMS, fMRI, and a Sham Controlled Arm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
研究概览
简要总结
This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. The trial will include structural and functional MRI, and behavioral measures obtained before, during, and after treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
时间窗: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.
次要结局
- Eating Disorder Inventory-3(Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment)
- Eating Disorder Examination Questionnaire (EDE-Q)(Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment)
研究者
Blake Woodside
Psychiatrist
University Health Network, Toronto