Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Tang-Du Hospital

Status: Unknown

Conditions: Anorexia Nervosa

Treatments: Procedure: Deep brain stimulation; Other: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02593695

ANDBS

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 65 years of age, male or female patients.
2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
3. BMI<16.
4. Long-term pharmacotherapy resistance.
5. Written informed consent.
6. normal intelligence and compliance

Exclusion criteria

1. 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；
2. History of severe neuropsychiatric disease；
3. Epilepsy；
4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
5. Severe diabetes ,severe cardiovascular and cerebrovascular disease；
6. Malignant tumor；
7. Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female；
8. Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Deep Brain Stimulation

Experimental group

Description:

Continuous deep brain stimulation of bilateral nucleus accumbens

Treatment:

Procedure: Deep brain stimulation

Standard Control

Active Comparator group

Description:

Fluoxetine

Treatment:

Other: Fluoxetine