Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT01678014 |
Recruitment Status : Unknown
Verified September 2012 by Wei Liu, Ruijin Hospital.
Recruitment status was: Recruiting
First Posted : September 3, 2012
Last Update Posted : September 5, 2012
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Condition or disease | Intervention/treatment | Phase |
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Anorexia | Procedure: Deep Brain Stimulation(DBS) Procedure: Capsulotomy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | October 2012 |
Estimated Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Anorexia
Anorexia patients
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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 |
- 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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The age was between 18 to 60 years old.
- Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR)
- Able to comply with all testing, follow-ups and study appointments and protocols.
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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:
- Patients with obviously encephalatrophy which was confirmed by MRI.
- Patients who were alcohol or substance dependence or abuse in the last 6 months.
- Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
- patients can not complete the 12 months follow-up.
- Patients with severe heart diseases or other organic problem who could not undergo the neurosurgery.
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Pregnancy
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678014
Contact: Wei Liu, MD | 64370045 ext 632068 | doctorliuwei@yahoo.cn |
China, Shanghai | |
Ruijin Hospital | Recruiting |
Shanghai, Shanghai, China, 200025 | |
Contact: Bomin Sun, MD 64370045 ext 632001 bominsun@sh163.net | |
Principal Investigator: Wei Liu, MD |
Study Director: | Bomin Sun, MD | Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine |
Responsible Party: | Wei Liu, Principal Investigator, Ruijin Hospital |
ClinicalTrials.gov Identifier: | NCT01678014 |
Other Study ID Numbers: |
DBSAN |
First Posted: | September 3, 2012 Key Record Dates |
Last Update Posted: | September 5, 2012 |
Last Verified: | September 2012 |
Anorexia DBS Capsulotomy Signs and Symptoms |
Anorexia Signs and Symptoms, Digestive |