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
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。
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
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