Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa

September 1, 2012 updated by: Wei Liu, Ruijin Hospital

Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia

Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and young adult women. There are many methods in the treatment of AN, such as family therapy, cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory to all current medical treatment and never fully recover and the standardized mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and capsulotomy are the most used methods which has been proved effective in obsessive and compulsive disorders, depression and other psychiatric disorders. Many case reports indicate that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there are some common pathways between AN and other psychiatric disorder. The investigators have a hypothesis that deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and young adult women. Although the etiology of AN is still unclear, it is unanimous that social, genetic and psychological factors appear to be involved in the onset and maintenance of this disorder. There are many methods in the treatment of AN, such as family therapy, cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory to all current medical treatment and never fully recover and the standardized mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic functional neurosurgery may be the better choice. Neurosurgery has been used in the treatment of mental diseases for more than fifty years. Deep brain stimulation and capsulotomy are the most used methods which has been proved effective in obsessive and compulsive disorders, depression and other psychiatric disorders. Many case reports indicate that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there are some common pathways between AN and other psychiatric disorders. The investigators have a hypothesis that deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Principal Investigator:
          • Wei Liu, MD
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The age was between 18 to 60 years old.
  2. Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR)
  3. Able to comply with all testing, follow-ups and study appointments and protocols.

  4. Treatment Resistance is defined by some or all of:

    • The duration of AN was more than 3 years and no period of good function.
    • The disorder severely affected the quality of life of the patient, preventing participation in normal activities such as work or study.
    • Chronic stable AN lasting at least 10 years.

Exclusion Criteria:

  1. Patients with obviously encephalatrophy which was confirmed by MRI.
  2. Patients who were alcohol or substance dependence or abuse in the last 6 months.
  3. Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
  4. patients can not complete the 12 months follow-up.
  5. Patients with severe heart diseases or other organic problem who could not undergo the neurosurgery.

  6. Pregnancy

    -

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anorexia
Anorexia patients
Procedure: Deep Brain Stimulation(DBS)
Deep Brain Stimulation(DBS)is a neurosurgical procedure which include the implantation of deep brain electrodes and the connect to an implantable pulse generator (IPG) that is implanted below the collarbone.
Procedure: Capsulotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anorexia Related Preoccupations and Rituals
Time Frame: April 2012-April 2014
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
April 2012-April 2014

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bomin Sun, MD, Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DBSAN

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