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Eating DisordersANfMRINCT01882023

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

An observational study of Eating Disorders, run by Uppsala University at 1 site in Sweden.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for
Eating Disorders
How many people
150 participants
Where
1 siteSweden
Study dates
May 2011to Dec 2031
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

  • On medication
  • Suffering from any other illnesses
  • Left handed
  • Metal implants which can impact the fMRI image
  • Severe claustrophobia
  • Pregnancy
  • Smoker
  • Regular alcohol drinker

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Röntgenavdelningen, Uppsala Academic Hospital

    Uppsala, Uppsala County, 751 24

Other trials in Sweden

About this study

Official title: Comparing Neural Responses to Explicit and Subliminal Food Images in EDNOS Patients and Healthy Controls Using fMRI

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.

Read the 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.

Keywords
EDNOS, adolescents, eating disorder, anorexia nervosa
Medical subject headings
Feeding and Eating Disorders, Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01882023
Study groupRoleWhat they receive
Eating disorderPatients currently in treatment for eating disorders.
Healthy ControlsAge- and gender matched healthy controls.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure functional differences in adolescents with eating disorders and healthy controls.

    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.

    Measured: 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.

Secondary outcomes (3)
  1. Measure structural differences in adolescents with eating disorders and healthy controls.

    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).

    Measured: 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.

  2. Develop knowledge of cognitive dysfunction in adolescents with eating disorders.

    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).

    Measured: 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.

  3. To examine whether clinical variables can predict neural activity.

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2013 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Why it stopped: Our trial is currently inactive due to the unavailability of certain facilities.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01882023
Sponsor's protocol ID
anfmri40
Acronym
ANfMRI
Status last verified
Apr 2026
First submitted
21 May 2013
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Brooks SJ, O'Daly OG, Uher R, Schioth HB, Treasure J, Campbell IC. Subliminal food images compromise superior working memory performance in women with restricting anorexia nervosa. Conscious Cogn. 2012 Jun;21(2):751-63. doi: 10.1016/j.concog.2012.02.006. Epub 2012 Mar 11.

    PubMed 22414738
  • Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.

    PubMed 21511208
  • Brooks SJ, O'Daly OG, Uher R, Friederich HC, Giampietro V, Brammer M, Williams SC, Schioth HB, Treasure J, Campbell IC. Differential neural responses to food images in women with bulimia versus anorexia nervosa. PLoS One. 2011;6(7):e22259. doi: 10.1371/journal.pone.0022259. Epub 2011 Jul 20.

    PubMed 21799807
  • Brooks SJ, O'Daly O, Uher R, Friederich HC, Giampietro V, Brammer M, Williams SC, Schioth HB, Treasure J, Campbell IC. Thinking about eating food activates visual cortex with reduced bilateral cerebellar activation in females with anorexia nervosa: an fMRI study. PLoS One. 2012;7(3):e34000. doi: 10.1371/journal.pone.0034000. Epub 2012 Mar 27.

    PubMed 22479499
  • Brooks SJ, Barker GJ, O'Daly OG, Brammer M, Williams SC, Benedict C, Schioth HB, Treasure J, Campbell IC. Restraint of appetite and reduced regional brain volumes in anorexia nervosa: a voxel-based morphometric study. BMC Psychiatry. 2011 Nov 17;11:179. doi: 10.1186/1471-244X-11-179.

    PubMed 22093442
  • Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.

    PubMed 20060105
  • Brooks SJ, Benedict C, Burgos J, Kempton MJ, Kullberg J, Nordenskjold R, Kilander L, Nylander R, Larsson EM, Johansson L, Ahlstrom H, Lind L, Schioth HB. Late-life obesity is associated with smaller global and regional gray matter volumes: a voxel-based morphometric study. Int J Obes (Lond). 2013 Feb;37(2):230-6. doi: 10.1038/ijo.2012.13. Epub 2012 Jan 31.

    PubMed 22290540
  • Olivo G, Wiemerslage L, Swenne I, Zhukovsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Correction: Limbic-thalamo-cortical projections and reward-related circuitry integrity affects eating behavior: A longitudinal DTI study in adolescents with restrictive eating disorders. PLoS One. 2017 Apr 20;12(4):e0176646. doi: 10.1371/journal.pone.0176646. eCollection 2017.

    PubMed 28426755
  • Olivo G, Wiemerslage L, Swenne I, Zhukowsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Limbic-thalamo-cortical projections and reward-related circuitry integrity affects eating behavior: A longitudinal DTI study in adolescents with restrictive eating disorders. PLoS One. 2017 Mar 1;12(3):e0172129. doi: 10.1371/journal.pone.0172129. eCollection 2017.

    PubMed 28248991
  • Olivo G, Zhou W, Sundbom M, Zhukovsky C, Hogenkamp P, Nikontovic L, Stark J, Wiemerslage L, Larsson EM, Benedict C, Schioth HB. Resting-state brain connectivity changes in obese women after Roux-en-Y gastric bypass surgery: A longitudinal study. Sci Rep. 2017 Jul 26;7(1):6616. doi: 10.1038/s41598-017-06663-5.

    PubMed 28747648
  • Gaudio S, Carducci F, Piervincenzi C, Olivo G, Schioth HB. Altered thalamo-cortical and occipital-parietal- temporal-frontal white matter connections in patients with anorexia and bulimia nervosa: a systematic review of diffusion tensor imaging studies. J Psychiatry Neurosci. 2019 Sep 1;44(5):324-339. doi: 10.1503/jpn.180121.

    PubMed 30994310
  • Olivo G, Swenne I, Zhukovsky C, Tuunainen AK, Saaid A, Salonen-Ros H, Larsson EM, Brooks SJ, Schioth HB. Preserved white matter microstructure in adolescent patients with atypical anorexia nervosa. Int J Eat Disord. 2019 Feb;52(2):166-174. doi: 10.1002/eat.23012. Epub 2019 Jan 24.

    PubMed 30676658
  • Olivo G, Swenne I, Zhukovsky C, Tuunainen AK, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Reduced resting-state connectivity in areas involved in processing of face-related social cues in female adolescents with atypical anorexia nervosa. Transl Psychiatry. 2018 Dec 13;8(1):275. doi: 10.1038/s41398-018-0333-1.

    PubMed 30546060
  • Gaudio S, Olivo G, Beomonte Zobel B, Schioth HB. Altered cerebellar-insular-parietal-cingular subnetwork in adolescents in the earliest stages of anorexia nervosa: a network-based statistic analysis. Transl Psychiatry. 2018 Jul 6;8(1):127. doi: 10.1038/s41398-018-0173-z.

    PubMed 29980676
  • Olivo G, Solstrand Dahlberg L, Wiemerslage L, Swenne I, Zhukovsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Atypical anorexia nervosa is not related to brain structural changes in newly diagnosed adolescent patients. Int J Eat Disord. 2018 Jan;51(1):39-45. doi: 10.1002/eat.22805. Epub 2017 Dec 7.

    PubMed 29215777

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01882023, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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