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Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Andres M. Lozano, University Health Network, Toronto.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01476540
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
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Purpose
Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and neurobiology of AN has led to a greater understanding of its underlying pathophysiology, although few significant advances in treatment have been made in the last half-century. The central features of AN, which include an intense fear of gaining weight, a refusal to maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding food, have been linked to dysfunction in key brain structures and circuits. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into structures believed to drive pathological behavior. The procedure is approved for the management of movement disorders, such as Parkinson's Disease, and has shown promising early results in the management of some psychiatric conditions, such as Major Depression. The purpose of this study is to explore the safety and initial efficacy of DBS, in patients with treatment resistant AN.
| Condition | Intervention | Phase |
|---|---|---|
| Anorexia Nervosa | Procedure: Deep Brain Stimulation | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa |
Further study details as provided by Andres M. Lozano, University Health Network, Toronto:
Primary Outcome Measures:
- Eating Disorder Related Preoccupations and Rituals [ Time Frame: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months ]
Secondary Outcome Measures:
- Depression [ Time Frame: Change from baseline in depression scores at 3 months, 6 months and 12 months ]Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI)
- Anxiety [ Time Frame: Change from baseline in anxiety scores at 3 months, 6 months and 12 months ]Beck Anxiety Inventory (BAI)
- Quality of Life [ Time Frame: Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months ]Health Survey Short Form (SF36), Quality of Life Scale
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Procedure: Deep Brain Stimulation
Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female or Male patients between age 20-60
- Diagnosis of Anorexia Nervosa, restricting or binge-purging subtype as defined by the Diagnostic and Statistical Manual (DSM-IVR)
-
Chronicity and/or Treatment Resistance as demonstrated by some or all of:
- A pattern of three year's duration of relentless unresponsiveness to repeated voluntary hospitalizations, characterized by failure to complete treatment of immediate weight relapse following treatment;
- pattern of increasing medical instability accompanied by refusal to participate in/lack of responsiveness to intensive expert treatment and increasing medical acuity, lasting at least two years and involving at least two episodes of involuntary feeding;
- A pattern of chronic stable AN lasting at least 10 years
- Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria:
- Any past or current evidence of psychosis
- Active neurologic disease such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
- Likely to relocate or move during the study's one year duration
- BMI less than 13
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of AN or not, that will result in significant risk from a surgical procedure.
- Pregnancy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476540
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476540
Contacts
| Contact: Nir Lipsman, MD | 416-790-1780 | nir.lipsman@utoronto.ca |
Locations
| Canada, Ontario | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T2S8 | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Andres M Lozano, MD, PhD | University Health Network, Toronto |
| Principal Investigator: | Blake Woodside, MD | Toronto General Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andres M. Lozano, Neurosurgeon, Professor of Surgery, University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01476540 History of Changes |
| Other Study ID Numbers: |
10-0991-A |
| Study First Received: | November 15, 2011 |
| Last Updated: | November 17, 2011 |
Additional relevant MeSH terms:
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive |
Signs and Symptoms Feeding and Eating Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 20, 2017