Working… Menu

Pilot Study of Deep Brain Stimulation for Severe 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01924598
Recruitment Status : Recruiting
First Posted : August 16, 2013
Last Update Posted : November 26, 2018
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. Exploration of underlying processes and novel treatment strategies is thus crucial. This is a pilot study of a novel translational approach to the investigation and treatment of severe AN. The aims are (1) to explore the safety, acceptability and feasibility of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning aberrant reward and optimise DBS targets. The study will involve 10 consenting adults with full mental capacity, and the nain protocol will last 15 months. . There is then optional annual follow ups for up to 5 years .It incorporates an ethical substudy including assessment of capacity and informed consent. It combines complementary forms of cutting edge neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in helping identify the best strategy for treating severe AN using DBS. Individuals with severe intractable AN will be eligible to take part. The study will be conducted in Oxford, United Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have preoperative ethical, neuroimaging and psychological assessments, A DBS operation in month 2, DBS switch on in month 3 month postoperatively . DBS will be targeted to the Nucleus accumbens, followed by a 12 month post switch on follow-up period with monthly joint neurosurgical psychiatric and psychological assessments and postoperative MEG scans . The study will further our understanding of food reward processes in general and AN in particular indeed promises to provide important information which may revolutionize future treatments. The proposal builds upon a body of research investigating the role of aberrant reward processes in AN and exploits our complementary research experience in AN using experimental behavioural strategies, fMRI , MEG and DBS to establish a powerful translational research strategy.

Condition or disease Intervention/treatment Phase
Severe Enduring Anorexia Nervosa Device: DBS to nucleus accumbens/anterior limb of internal capsule Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hungry for Reward : A Pilot Investigation of the Ethics, Practice and Neural Basis of Deep Brain Stimulation to the Nucleus Accumbens in Severe Intractible Anorexia Nervosa.
Study Start Date : July 2013
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: DBS surgery Device: DBS to nucleus accumbens/anterior limb of internal capsule
deep brain stimulation followed by 12 month post switch on followup

Primary Outcome Measures :
  1. Adverse events associated with surgery or stimulation [ Time Frame: 13 months post operatively ]
  2. Eating Disorder pathology [ Time Frame: 15 months ]
    Global EDE Score, Yale brown ED scale

  3. Eating Disorder Pathology [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Comorbid psychiatric symptoms [ Time Frame: 15 months ]
    anxiety, depression, obsessionality,

  2. Hamilton score [ Time Frame: 15 months ]
    hamilton depression rating scale

  3. MEG 'Resting State Network' [ Time Frame: 15 months ]
    Neural changes pre-post DBS

  4. Food Reward processing [ Time Frame: 15 months ]
    Leeds-Oxford food preference task: ' implicit 'wanting' of low vs hi cal foods, as indexed by reaction times to hi vs low cal food pictures.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Primary diagnosis: Anorexia Nervosa according to the DSMIV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition)criteria based on a psychiatric interview
  2. Illness duration of severe AN > 7 years
  3. Disabling severity with substantial functional impairment
  4. Female Gender and right handed
  5. Treatment refractoriness, defined as lack of response to two or more typical modes of treatment, such as inpatient weight restoration, psychotherapy and psychopharmacology
  6. Severely underweight: BMI >13 <16
  7. Age: 20-65 years old
  8. Written informed consent
  9. Able to fully understand the consequences of the procedure
  10. English speaking and able to answer the study questions fluently
  11. Having the mental capacity to make provide informed consent to research participation


Exclusion Criteria:

  1. Unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical conditions due to underweight in which surgery/anaesthesia is contraindicated)
  2. Treatable underlying cause of anorexia/underweight
  3. Parkinson's disease, dementia, epilepsy
  4. History of schizophrenia/ psychosis, bipolar disorder
  5. Alcohol or substance abuse (including benzodiazepines) during the last 6 months
  6. Current severe major depressive or Tic disorder
  7. Antisocial or Severe Borderline Personality Disorder
  8. Standard MRI scan exclusion criteria (pregnancy, pacemaker and metals contraindicated for MRI except for the DBS implantation and stimulator itself)
  9. Current Involuntary patient


Information from the National Library of Medicine

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 identifier (NCT number): NCT01924598

Layout table for location contacts
Contact: Rebecca Park, MD PhD MRCPSych
Contact: Tipu Aziz, MD FRCPsyc FMed Sci

Layout table for location information
United Kingdom
University of Oxford Dept Psychiatry , Warneford Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX37JX
Contact: Rebecca J Park, MDPhD    +44 1865 618299   
Contact: Tipu Aziz, MD   
Principal Investigator: Rebecca j Park, MDPhd         
Principal Investigator: Tipu Aziz, MD         
Nuffield Dept Surgery, University of oxford Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Layout table for investigator information
Principal Investigator: Tipu Aziz, MD University of Oxford
Principal Investigator: Rebecca Park, MD Phd University of Oxford

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford Identifier: NCT01924598     History of Changes
Other Study ID Numbers: SC/13/0267
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Oxford:
Anorexia Nervosa
Treatment Development
functional MRI
Reward processing
Habit formation
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders