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Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02593695
Enrollment
10
Registered
2015-11-02
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens

Brief summary

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.

Interventions

PROCEDUREDeep brain stimulation

Deep brain stimulation of bilateral nucleus accumbens

OTHERFluoxetine

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

Sponsors

Tang-Du Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
BMI6 month

Secondary

MeasureTime frameDescription
weight6 month
Yale-Brown Obsessive Compulsive Scale6 monthYale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Self-Rating Depression Scale6 monthSelf-Rating Depression Scale(SDS) is used to evaluate depression symptom.
The Symptom Checklist-906 monthThe Symptom Checklist-90(SCL-90) is used to evaluate general status.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026