ACTRN12618002047279Not yet recruiting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
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- The University of Queensland
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Investigators
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