跳至主要内容
临床试验/NCT04409704
NCT04409704已完成1 期

Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series

University Health Network, Toronto0 个研究点目标入组 60 人开始时间: 2011年12月11日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
60
主要终点
Eating Disorder Examination (EDE)

研究概览

简要总结

This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is heavily implicated in the regulation of mood and affect, and has been suggested to be involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by improved regulation of mood and affect. Improvements in important areas of comorbidity might allow for better response to intensive treatment for AN and BN, and reduce relapse rates after such treatment. The DMPFC may be a more appropriate target for compared to the Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in the past. Our initial preliminary pilot work has noted unexpected and significant improvements in some core ED symptoms (bingeing and purging) and in important areas of comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have allowed some treatment resistant patients to either complete intensive treatment or be successful in maintaining their progress post intensive treatment. Subjects will receive up to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via psychometric measures, and pre and post fMRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • Patients will be included if they:
  • Are voluntary and competent to consent to treatment.
  • Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the last 6 months at minimum

排除标准

  • Patients will be excluded if they have:
  • Past or current neurological illness
  • Comorbid schizophrenia
  • Current suicidal intent or plan
  • Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)

结局指标

主要结局

Eating Disorder Examination (EDE)

时间窗: Change from baseline to 1 week post-treatment completion.

Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验