CClinicalTrials.gg
Status unknownNCT01678014Updated Sep 5, 2012

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

A Phase 1 interventional study of Deep Brain Stimulation(DBS) and Capsulotomy in Anorexia, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-09-05.

Sponsored by Ruijin Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Anorexia

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Keywords

  • Anorexia
  • DBS
  • Capsulotomy
  • Signs and Symptoms
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's planned enrollment of 48 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

    -

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Anorexia

    Anorexia patients

    Procedure: Deep Brain Stimulation(DBS) · Procedure: Capsulotomy

Interventions

  • ProcedureDeep 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.

  • ProcedureCapsulotomy
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What researchers measure

Primary outcomes

  1. Anorexia Related Preoccupations and Rituals

    Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months

    Time frame: April 2012-April 2014

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital
    Shanghai, Shanghai 200025, China
    • Bomin Sun, MD · Contact · bominsun@sh163.net · 64370045
    • Wei Liu, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01678014
Lead sponsor
Ruijin Hospital
Responsible party
Wei Liu (Principal Investigator, Ruijin Hospital) — Principal investigator
First posted
Sep 3, 2012
Start date
Apr 2012
Primary completion
Oct 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Sep 5, 2012

Study contacts

Wei Liu, MD
Contact
doctorliuwei@yahoo.cn
64370045 ext. 632068
Bomin Sun, MD
study director · Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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