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Comparing Neural Responses to Food Images in EDNOS Patients and Healthy Controls Using fMRI (ANfMRI)

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ClinicalTrials.gov Identifier: NCT01882023
Recruitment Status : Unknown
Verified December 2014 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:

Currently, there is not a robust, testable neural model available that sufficiently explains the development and maintenance of anorexia nervosa (AN) a severe, often fatal, adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological techniques, our objective is to identify neural mechanisms in the adolescent brain underlying AN. This is of high clinical relevance in as much as it will provide a robust platform for a diagnostic battery so that physicians can identify those who are prone to develop AN at a very early stage of life.

The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in adolescents who have recently been diagnosed with AN, with a battery of cognitive tests during a series of clinical visits. 2) To provide a scientific basis for our knowledge about how the brain of an adolescent with an eating disorder differs from that of a healthy adolescent, by conducting functional and structural magnetic resonance imaging on adolescent females with AN.


Condition or disease
Eating Disorders

Detailed Description:

Adolescents with eating disorders have debilitating cognitive disturbances that impact on their social, educational and physical health. One cognitive trait that is found to form core cognitive disturbances in AN is superior working memory (WM). WM is the ability to ruminate on a cognitive strategy while attending to the details of another task, excluding non-relevant stimuli, and is linked to activation of the dorsolateral prefrontal cortex (DLPFC). By administering functional Magnetic Resonance Imaging (fMRI) we have recently found that females with AN have increased activation in the DLPFC and reduced appetitive brain responses when thinking about eating food shown in visual images. This suggests that the increased WM capacity in AN may serve to suppress food intake, but this has not yet been clarified. In line with this assumption, we have also shown that restraint of appetite in those with AN was linked to greater plasticity in the DLPFC. Furthermore, Transcranial Magnetic Stimulation (TMS) of the DLPFC reduces appetitive responses to food stimuli in adults with eating disorders. Conversely, we have shown that being obese is linked to reduced structure and abnormal function in the DLPFC, as well as reduced attentional control/WM performance. Therefore, it is likely that DLPFC-related WM function is associated with eating disorders, particularly cognitive restraint of appetite.

It is likely that the interaction between appetitive brain regions and specific prefrontal cortex (PFC) cognitions determines whether an adolescent develops anorexia nervosa. We aim to provide neuropsychological and brain imaging measures showing how a specific cognitive function is linked to early-onset disordered eating behaviour, and we will do this before and after standard clinical treatment. We suggest that such understanding could enable school nurses to use the unique paradigm we use in our fMRI study, to detect illness before it damages the child's life and becomes difficult to treat.

The study has now been increased to include genetic components to examine the genetic and epigenetic variation for genes found to be linked with eating disorders.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparing Neural Responses to Explicit and Subliminal Food Images in EDNOS Patients and Healthy Controls Using fMRI
Study Start Date : May 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Group/Cohort
Eating disorder
Patients currently in treatment for eating disorders
Healthy Controls
Age- and gender matched healthy controls



Primary Outcome Measures :
  1. Measure functional differences in adolescents with eating disorders and healthy controls. [ Time Frame: This is measured during scanning shortly after patient admittance to treatment, and one year later. Controls have their scans shortly after being recruited to the study, then again 1 year later. ]
    The analysis of each groups' neural activity will be carried out with statistical parametric mapping (SPM) implemented in Matlab. This will compare the statistical parametric maps between the group using ANOVAs, ANCOVAs and t-tests.


Secondary Outcome Measures :
  1. Measure structural differences in adolescents with eating disorders and healthy controls. [ Time Frame: This is measured during scanning shortly after patient admittance to treatment, and one year later. Controls have their scans shortly after being recruited to the study, then again 1 year later. ]
    To determine any structural differences, matlab will be used. With this one can upload the T1 structural scanning data and determine the volume of each subject's brain, and even compute the volume of each tissue (CBF, white matter and grey matter).

  2. Develop knowledge of cognitive dysfunction in adolescents with eating disorders. [ Time Frame: The cognitive measures are conducted shortly after recruitment of the study. The subjects are given the questionnaires upon their first meeting, and are posted back to us shortly after. ]
    Any cognitive dysfunction will be measured with a working memory task in the scanner (N-back task). Further, various clinical variables will be measured with the use of questionnaires such as Eating Disorder Examination Questionnaire (EDEQ), Perceived Stress Scale (PSS), Montgomery-Åsberg Depression Rate Scale (MADRS), Eating Disorder Inventory (EDI), Barratts Impulsivity Scale (BIS), Obsessive Compulsive Inventory - Revised (OCI R), and Multidimensional Perfectionism Scale (MPS).

  3. To examine whether clinical variables can predict neural activity. [ Time Frame: The neural activity is measured during scanning shortly after subject recruitment, and one year later. The clinical measurements are measured with questionnaires given to them on their first meeting after recruitment, which are later posted back to us. ]
    The analysis of each groups' neural activity will be carried out with statistical parametric mapping (SPM) implemented in Matlab. This will compare the statistical parametric maps between the group using ANOVAs, ANCOVAs and t-tests. The clinical variables will be measured with the use of questionnaires such as Eating Disorder Examination Questionnaire (EDEQ), Perceived Stress Scale (PSS), Montgomery-Åsberg Depression Rate Scale (MADRS), Eating Disorder Inventory (EDI), Barratts Impulsivity Scale (BIS), Obsessive Compulsive Inventory - Revised (OCI R), and Multidimensional Perfectionism Scale (MPS). These will be used in a multiple regression analysis carried out in SPM to see whether there is any correlation between the scores of the questionnaires and the brain activity of the groups.


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Half of the cohort are patients recruited from the eating disorder clinic. All subjects in the study are adolescent females residing in the Uppsala area.
Criteria

Inclusion Criteria:

  • Females
  • Age 13 - 18 yrs
  • Right handed
  • For controls: BMI within the "normal" range
  • For patients: Be admitted to treatment for an eating disorder

Exclusion Criteria:

  • On medication
  • Suffering from any other illnesses
  • Left handed
  • Metal implants

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 ClinicalTrials.gov identifier (NCT number): NCT01882023


Contacts
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Contact: Samantha Brooks, Ph.D. samantha.brooks@neuro.uu.se

Locations
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Sweden
Röntgenavdelningen, Uppsala Academic Hospital Recruiting
Uppsala, Uppsalalän, Sweden, 751 24
Contact: Samantha J Brooks, PH.D       samantha.brooks@neuro.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Samantha J Brooks, Ph.D. Uppsala University
Publications:

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01882023    
Other Study ID Numbers: anfmri40
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Uppsala University:
EDNOS
adolescents
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders