PINS Stimulator System to Treat Severe Anorexia Nervosa

Study Overview
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Brief Summary
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Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.

Official Title
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PINS Stimulator System to Treat Severe Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients aged 20-60 years. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). Chronicity or treatment resistance shown by some or all of: A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment. A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding. A pattern of chronic stable anorexia nervosa that has lasted at least 10 years. Able to provide informed consent. Able to comply with all testing, follow-ups, and study appointments and protocols. Exclusion Criteria: Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems. Patients with serious infectious disease. Patients with history of serious neurological or psychiatrical diseases. Person with history of HIV infection or serious malnutrition. Dependent upon and addicted to multiple drugs. Any contraindication to MRI or PET scanning. Body-mass index less than 13. Attended some other trials within one year.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation | Device: Deep Brain Stimulation<br>* DBS Implant Stimulation<br>* Other names: Rechargeable Neurostimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Related Preoccupations and Rituals |  | Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | Change from baseline at 3 months, 6 months and 12 months | 
| Health Survey Short Form (SF-36) |  | Change from baseline at 3 months, 6 months and 12 months |