Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Study Overview
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Brief Summary
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Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.

Official Title
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Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Procedure: Deep brain stimulation
* Other: Fluoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years of age, male or female patients. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). BMI<16. Long-term pharmacotherapy resistance. Written informed consent. normal intelligence and compliance Exclusion Criteria: Surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； History of brain trauma； History of severe neuropsychiatric disease； Epilepsy； severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension； Severe diabetes ,severe cardiovascular and cerebrovascular disease； Malignant tumor； Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female； Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Continuous deep brain stimulation of bilateral nucleus accumbens | Procedure: Deep brain stimulation<br>* Deep brain stimulation of bilateral nucleus accumbens<br>* Other names: DBS;|
| Active Comparator: Standard Control<br>Fluoxetine | Other: Fluoxetine<br>* Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 6 month | 
| Yale-Brown Obsessive Compulsive Scale | Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom. | 6 month | 
| Self-Rating Depression Scale | Self-Rating Depression Scale(SDS) is used to evaluate depression symptom. | 6 month | 
| The Symptom Checklist-90 | The Symptom Checklist-90(SCL-90) is used to evaluate general status. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens