Pilot Study of Deep Brain Stimulation for Severe Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01924598
First received: July 22, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 3 consenting adults with full mental capacity, and will last 12 months. It incorporates an ethical substudy including assessment of capacity and informed consent. It combines complementary forms of cutting edge neuroimaging including DTI (diffusion tensor imaging), 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, then DBS to the Nucleus accumbens, followed by a 9 month followup period with 6-weekly joint neurosurgical psychiatric and psychological assessments and 3-monthly 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 (Park), fMRI (Harmer), MEG (Nobre) and DBS & DTI (Aziz) to establish a powerful translational research strategy. The study is part of an MRC programme and linked with a separate casecontrol multimodal imaging study generating mutually informative data.


Condition Intervention
Severe Intractable Anorexia Nervosa
Device: Deep Brain Stimulation 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 Translational Study of Brain Processes Underpinning Anorexia Nervosa I: A Pilot Investigation of the Ethics, Practice and Neural Basis of Deep Brain Stimulation to the Nucleus Accumbens in Severe Intractible Anorexia Nervosa.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Adverse events associated with surgery or stimulation [ Time Frame: 9 months post operatively ] [ Designated as safety issue: Yes ]
  • Eating Disorder pathology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Global EDE Score

  • Eating Disorder Pathology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    BMI


Secondary Outcome Measures:
  • Comorbid psychiatric symptoms [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    anxiety, depression, obsessionality

  • Food Reward processing [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Ventral striatal response to hi vs low cal food pics as measured by fMRI

  • Habit formation (adapted 'fabulous fruit task') [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Habit formation as indexed by persistence of response to devalued contingencies

  • MEG 'Resting State Network' [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Neural changes pre-post DBS

  • White matter integrity-DTI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Food Reward processing [ Time Frame: 9 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.

  • Habit formation(noise avoidance task) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Habit formation as indexed by persistence of response to devalued stimuli


Estimated Enrollment: 3
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Deep Brain Stimulation to nucleus accumbens/anterior limb of internal capsule
    6 week blocks of single blind periods of sham or active deep brain stimulation over 9 month post operative followup
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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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

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  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

Contacts
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

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

Additional Information:
No publications provided

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: August 14, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Research Councils UK

Keywords provided by University of Oxford:
Anorexia Nervosa
Treatment Development
Capacity
Neuroimaging
Magnetoencephalography
Diffusion Tensor Imaging
functional MRI
Reward processing
Habit formation

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

ClinicalTrials.gov processed this record on July 20, 2014