Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02593695
• Other study ID #: ANDBS
• Status: Active, not recruiting
• Phase: N/A
• First received: October 14, 2015
• Last updated: November 9, 2015
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Procedure:
• Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens

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

Locations

Country	Name	City	State
China	Department of neurosurgery, Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		6 month	No
Secondary	weight		6 month	No
Secondary	Yale-Brown Obsessive Compulsive Scale	Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.	6 month	No
Secondary	Self-Rating Depression Scale	Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.	6 month	No
Secondary	The Symptom Checklist-90	The Symptom Checklist-90(SCL-90) is used to evaluate general status.	6 month	No