Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

NCT01476540 | Completed

• 1 other identifier: 10-0991-A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Related Preoccupations and Rituals

  Eating Disorder Related Preoccupations and Rituals scores

  Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months

Secondary Outcomes (3)

• Depression

  Change from baseline in depression scores at 3 months, 6 months and 12 months

• Anxiety

  Change from baseline in anxiety scores at 3 months, 6 months and 12 months

• Quality of Life questionnaire score through change from baseline compared to post-implant visit

  Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Deep Brain Stimulation

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

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.

Deep Brain Stimulation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (2)

• Lipsman N, Lam E, Volpini M, Sutandar K, Twose R, Giacobbe P, Sodums DJ, Smith GS, Woodside DB, Lozano AM. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial. Lancet Psychiatry. 2017 Apr;4(4):285-294. doi: 10.1016/S2215-0366(17)30076-7. Epub 2017 Feb 24.

  PMID: 28238701 DERIVED

• Lipsman N, Woodside DB, Giacobbe P, Hamani C, Carter JC, Norwood SJ, Sutandar K, Staab R, Elias G, Lyman CH, Smith GS, Lozano AM. Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial. Lancet. 2013 Apr 20;381(9875):1361-1370. doi: 10.1016/S0140-6736(12)62188-6. Epub 2013 Mar 7.

  PMID: 23473846 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Andres M Lozano, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Blake Woodside, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor of Surgery

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

CA (1)