Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Deep Brain Stimulation

Continuous deep brain stimulation of bilateral nucleus accumbens

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type PROCEDURE

Deep brain stimulation of bilateral nucleus accumbens

Standard Control

Fluoxetine

Group Type ACTIVE_COMPARATOR

Fluoxetine

Intervention Type OTHER

Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Interventions

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Deep brain stimulation

Deep brain stimulation of bilateral nucleus accumbens

Intervention Type PROCEDURE

Fluoxetine

Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Intervention Type OTHER

Other Intervention Names

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DBS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No