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Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01476540
Recruitment Status : Unknown
Verified November 2011 by Andres M. Lozano, University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Anorexia Nervosa Procedure: Deep Brain Stimulation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Study Start Date : July 2011
Estimated Primary Completion Date : March 2013
Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. Anxiety [ Time Frame: Change from baseline in anxiety scores at 3 months, 6 months and 12 months ]
    Beck Anxiety Inventory (BAI)

  3. 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


Eligibility Criteria
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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:

    1. 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;
    2. 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;
    3. 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
 Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders