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Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
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
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression [ Time Frame: Change from baseline in depression scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: Canada: Health Canada

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 30, 2016