Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

November 9, 2015 updated by: Guodong Gao, Tang-Du Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Department of Neurosurgery, Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
Procedure: Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
Other Names:
  • DBS
ACTIVE_COMPARATOR: Standard Control
Fluoxetine
Other: Fluoxetine
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI
Time Frame: 6 month
6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (ESTIMATE)

November 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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