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 人开始时间: 2018年12月21日最近更新: 2019年12月10日

适应症

试验速览

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•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)

•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

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