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History of Changes for Study: NCT01476540
Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Latest version (submitted October 28, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 17, 2011 None (earliest Version on record)
2 October 28, 2019 Recruitment Status, Study Status, Arms and Interventions, Study Design, Contacts/Locations, Outcome Measures and Study Description
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Study NCT01476540
Submitted Date:  November 17, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 10-0991-A
Brief Title: Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Official Title: Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2011
Overall Status: Recruiting
Study Start: July 2011
Primary Completion: March 2013 [Anticipated]
Study Completion:
First Submitted: November 15, 2011
First Submitted that
Met QC Criteria:
November 17, 2011
First Posted: November 22, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 17, 2011
Last Update Posted: November 22, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Health Network, Toronto
Responsible Party: Principal Investigator
Investigator: Andres M. Lozano
Official Title: Neurosurgeon, Professor of Surgery
Affiliation: University Health Network, Toronto
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Anorexia Nervosa
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Nir Lipsman, MD
Telephone: 416-790-1780
Email: nir.lipsman@utoronto.ca
Study Officials: Andres M Lozano, MD, PhD
Principal Investigator
University Health Network, Toronto
Blake Woodside, MD
Principal Investigator
Toronto General Hospital
Locations: Canada, Ontario
Toronto Western Hospital
[Recruiting]
Toronto, Ontario, Canada, M5T2S8
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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