Pilot Study of Deep Brain Stimulation for Severe Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Oxford
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
First received: July 22, 2013
Last updated: December 8, 2015
Last verified: December 2015
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 6 consenting adults with full mental capacity, and will last 15 months. 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 Intervention
Severe Enduring Anorexia Nervosa
Device: DBS to nucleus accumbens/anterior limb of internal capsule

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Adverse events associated with surgery or stimulation [ Time Frame: 13 months post operatively ] [ Designated as safety issue: Yes ]
  • Eating Disorder pathology [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Global EDE Score, Yale brown ED scale

  • Eating Disorder Pathology [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comorbid psychiatric symptoms [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    anxiety, depression, obsessionality,

  • Hamilton score [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    hamilton depression rating scale

  • MEG 'Resting State Network' [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Neural changes pre-post DBS

  • Food Reward processing [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 6
Study Start Date: July 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DBS to nucleus accumbens/anterior limb of internal capsule
    deep brain stimulation followed by 12 month post switch on followup
  Show Detailed Description


Ages Eligible for Study:   20 Years to 65 Years
Genders 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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924598

Contact: Rebecca Park, MD PhD MRCPSych rebecca.park@psych.ox.ac.uk
Contact: Tipu Aziz, MD FRCPsyc FMed Sci tipu.aziz@nds.ox.ac.uk

United Kingdom
Oxford Health NHS foundation trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX37JX
Contact: Rebecca J Park, MDPhD       rebecca.park@psych.ox.ac.uk   
Principal Investigator: Rebecca j Park, MDPhd         
Sponsors and Collaborators
University of Oxford
Principal Investigator: Tipu Aziz, MD University of Oxford
Study Director: Rebecca Park, MD Phd University of Oxford
  More Information

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01924598     History of Changes
Other Study ID Numbers: SC/13/0267 
Study First Received: July 22, 2013
Last Updated: December 8, 2015
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Research Councils UK

Keywords provided by University of Oxford:
Anorexia Nervosa
Treatment Development
functional MRI
Reward processing
Habit formation

Additional relevant MeSH terms:
Anorexia Nervosa
Feeding and Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 22, 2016