Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01476540|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Device: Deep Brain Stimulation||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Deep Brain Stimulation
Deep Brain Stimulation
Device: 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.
- 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 ]Eating Disorder Related Preoccupations and Rituals scores
- 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)
- Anxiety [ Time Frame: Change from baseline in anxiety scores at 3 months, 6 months and 12 months ]Beck Anxiety Inventory (BAI)
- Quality of Life questionnaire score through change from baseline compared to post-implant visit [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476540
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Andres M Lozano, MD, PhD||University Health Network, Toronto|
|Principal Investigator:||Blake Woodside, MD||Toronto General Hospital|