跳至主要内容
临床试验/ACTRN12618002047279
ACTRN12618002047279
尚未招募
未知

Efficacy and safety of Deep Brain Stimulation (DBS) of the Nucleus Accumbens for Treatment Resistant Severe and Enduring Anorexia Nervosa: A Phase 1 Open Trial

The University of Queensland0 个研究点目标入组 10 人2018年12月21日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
未指定
发起方
The University of Queensland
入组人数
10
状态
尚未招募
最后更新
6年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2018年12月21日
结束日期
待定
最后更新
6年前
研究类型
Interventional
性别
All

研究者

入排标准

入选标准

  • Participants will be selected initially on psychiatric criteria for fulfilling a clear diagnosis of, restricting or binge\-purging subtype, as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM\-5\)
  • Be of a severe, enduring and treatment\-resistant AN:
  • \* BMI between 13 to 17\.5
  • \* Duration of severe AN of at least 7 years
  • \* Treatment resistance: lack of response to at least two treatments such as evidence\-based psychotherapy, day treatment and inpatient weight regain
  • Significant functional impairment
  • Age 18\-65 years
  • Able to freely provide verbal and written informed consent
  • Able to comply with all assessment, protocols and follow\-ups
  • Approved for treatment by the Mental Health Review Tribunal (MHRT)

排除标准

  • Active neurological disease such as epilepsy
  • Any past or present evidence of psychosis; current severe depressive disorder; past or present diagnosis of bipolar disorder, Antisocial Personality Disorder or severe Borderline Personality Disorder
  • Unstable physical condition contraindicating surgery or anaesthesia
  • Alcohol or substance use disorder in the previous six months, excluding nicotine and caffeine
  • Any contradiction to MRI scanning
  • Likely to move or relocate during the study’s 18\-month duration
  • Participant on an Involuntary Treatment Order under Mental Health Act

结局指标

主要结局

未指定

相似试验