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
- 1
- 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
- •Voluntary and Competent to Consent
- •MINI confirmed Diagnosis of Bulimia Nervosa OR Anorexia Nervosa, Binge/Purge subtype
- •Outpatient
- •Between the ages of 18-65
- •Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
- •Must adhere to research schedule.
- •Pass the TMS Safety Screening Questionnaire.
- •Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
排除标准
- •Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
- •Have active suicidal intent
- •Are pregnant
- •Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- •Have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than the ED
- •Have received rTMS for any previous indication due to the potential compromise of subject blinding.
研究组 & 干预措施
High-frequency rTMS
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
干预措施: High-frequency rTMS (Device)
Low-frequency rTMS
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
干预措施: Low-frequency rTMS (Device)
Sham rTMS
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
干预措施: Sham rTMS (Device)
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