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
University Health Network, Toronto
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.