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CompletedNCT01476540Updated Oct 30, 2019

Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

An interventional study of Deep Brain Stimulation in Anorexia Nervosa, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
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Study 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.

Read the detailed description

Anorexia nervosa is a chronic, and debilitating psychiatric disorder associated with the highest mortality rate of any psychiatric condition. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress have been made in altering the natural history of the condition or its outcomes. It has further become increasingly accepted that the thoughts and behaviors at the root of AN derive from dysfunctional neuroanatomic circuits, whose activity and deviations can be detected with sophisticated neuroimaging techniques. Much progress has also been made in mapping the psychology of the illness to underlying neuroanatomic and neurophysiologic processes that drive and maintain these behaviors, even in the face of severe starvation and impending death. Dysfunctional reward processing, compulsive hyperactivity, chronic anxiety and depression, all suggest that AN shares much in common with other conditions, such as OCD, for which surgical therapy has been tried, and met with success.

Deep Brain Stimulation is a neurosurgical tool that has been widely used for over twenty years. Most of the experience with DBS comes from the movement disorder literature where significant success has been had with the management of disabling Parkinson's disease (PD) and dystonia. The most experience so far has been in Parkinson's disease where well over 50,000 patients globally have received the operation. DBS is believed to work by using small amounts of electricity to disrupt the activity of brain structures that produce troublesome symptoms. DBS has also been used in psychiatric patients, both as part of treatment and research, in cases of Obsessive-Compulsive Disorder (OCD), and research, in cases of Depression. Current research suggests that there are similarities between Anorexia Nervosa and conditions such as OCD and depression. Given that DBS has shown promise in the treatment of those conditions, this trial was designed to see if it could be an effective therapy for Anorexia Nervosa as well.

This study would be the first exploration of a surgical therapy for refractory AN. The rationale stems from clear and robust evidence pointing at a dysfunctional cortical-subcortical loop driving abnormal behavior, with several important nodes in the loop being particularly important, and recurring, players. The subgenual cingulate plays a role in affective decision making, reward processing, as well as subsequent anxiety and dysphoric mood.

There are currently no brain based, targeted therapies for AN. The scientific significance of this study will be:

i) The first clinical trial exploring deep brain stimulation in an eating disorder population

ii) The first demonstration of the influence of deep brain stimulation on dysfunctional reward processing with co-morbid anxiety/dysphoria

iii) The first 'brain-based' treatment for any eating disorder

02

Conditions studied

  • Anorexia Nervosa
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 15 is below the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Deep Brain Stimulation

    Deep Brain Stimulation

    Device: Deep Brain Stimulation

Interventions

  • DeviceDeep 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.

06

What researchers measure

Primary outcomes

  1. Eating Disorder Related Preoccupations and Rituals

    Eating Disorder Related Preoccupations and Rituals scores

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

Secondary outcomes

  1. Depression

    Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI)

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

  2. Anxiety

    Beck Anxiety Inventory (BAI)

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

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

    Health Survey Short Form (SF36), Quality of Life Scale

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

07

Study locations

1 site
  • Toronto Western Hospital
    Toronto, Ontario M5T2S8, Canada
08

References and documents

Publications

  • 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. PubMed 28238701 ↗
  • 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. PubMed 23473846 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01476540
Lead sponsor
University Health Network, Toronto
Responsible party
Andres M. Lozano (Neurosurgeon, Professor of Surgery, University Health Network, Toronto) — Principal investigator
First posted
Nov 22, 2011
Start date
Jul 2011
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Oct 30, 2019

Study contacts

Andres M Lozano, MD, PhD
principal investigator · University Health Network, Toronto
Blake Woodside, MD
principal investigator · Toronto General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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