A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Weekly Binge/Purge Frequency on Eating Disorder Examination
研究概览
简要总结
This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa.
The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.
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
- Double (Participant, 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
- 是
入选标准
- •Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire
排除标准
- •Diagnosis of another psychiatric disorder, except MDD.
- •Any rTMS counter-indications:
- •History of seizures
- •Metal in head
- •Currently pregnant
- •Having received rTMS for any reason in the past as this would interfere with participant blinding.
研究组 & 干预措施
Active rTMS (Anorexia Nervosa)
Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS).
For the second session each day the patients in the anorexia group will receive low-frequency treatment (1 Hz, 60 second cycles, 30 second inter-train interval, 20 trains, 1200 total pulses) at 120% of the resting motor threshold to the orbitofrontal cortex
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Active rTMS (Bulimia Nervosa)
Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS).
For the second session each day the patients in the bulimia group will receive high-frequency (10 Hz, 5 second cycles, 50 pulses, 25 second inter-train interval, 60 trains, 3000 total) at 120% of the resting motor threshold treatment to the left dorsomedial prefrontal cortex
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Sham rTMS (Anorexia Nervosa)
Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Anorexia Nervosa group however their will be no actual brain stimulation.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
Sham rTMS (Bulimia Nervosa)
Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Bulimia Nervosa group however their will be no actual brain stimulation.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Weekly Binge/Purge Frequency on Eating Disorder Examination
时间窗: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Outcome measured by change of binge/purge episodes from baseline to the end of treatment. If the participant has a final score of 0 binges and 0 purges they will be considered in remission. A 50% improvement will be defined as a response to the rTMS.
次要结局
- Change in Beck Anxiety Inventory (BAI)(baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.)
- Change in Beck Depression Inventory (BDI)(baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.)