Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450239
Other study ID # R47959/RE004
Secondary ID
Status Completed
Phase N/A
First received February 15, 2018
Last updated April 3, 2018
Start date May 5, 2017
Est. completion date February 7, 2018

Study information

Verified date April 2018
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will examine compulsivity in those who have recovered from anorexia nervosa, using a multi-modal MRI study. The neural activation of key fronto-striatal areas will be explored using a task which examines set-shifting and reversal-learning, two key components of compulsivity. Additionally, the functional networks displayed during resting-state MRI will be examined between groups, as will the neurochemicals present (using Magnetic Resonance spectroscopy).


Description:

The investigators will perform four different MRI (Magnetic Resonance Imaging) scans during one scanning session on those who have recovered from anorexia nervosa (AN) and healthy controls.

Participants will come to the Warneford hospital for a 2.5 hour screening visit, which will consist of questionnaires and interviews to determine their medical and psychiatric history and current mood, along with a practice of the task they'll do in the scanner. Participants will also complete two tasks which measure compulsivity and can be correlated with their brain activity in the scans. The investigators will also go through a scanning safety form with participants at this time.

Participants will also attend a scanning visit, which will last 1.5 hours. One of the scans will look at how the brain responds to a particular task. This task will examine aspects of compulsivity (which is rigidly repeating actions that aren't rewarding) by using face and house stimuli (see reference 1).

The investigators will also perform a scan when participants are at rest, in order to see if there are differences in the way areas of the brain connect to each other who used to have AN. The scientific literature indicates that there may be differences in the some key brain networks, including one which is thought to be involved in reflection and the self (the default mode network), which might also be linked to compulsivity (see reference 2).

This study will also further investigate some initial pilot findings using Magnetic Resonance Spectroscopy, which allows researchers to examine the levels of different neurochemicals in the brain. It has been found that those with a current diagnosis of AN have lower levels of glutamate (a key brain chemical) compared to healthy controls, which is a finding we seek to extend in those who have recovered from AN (see reference 3).

Aims: The investigators aim to see whether there are differences in the brains of those who have recovered from anorexia compared to those who have never had an anorexia diagnosis. This will be both at rest, and whilst participants are doing a task which measures compulsivity, as compulsivity is thought to be a particular risk factor for eating disorders.

Value: If the investigators are able to identify differences, these might reflect underlying risk factors for eating disorders, which could lead to potential future treatments or prevention schemes.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 7, 2018
Est. primary completion date February 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Able and willing to give informed consent

- BMI over 18.5 and has remained so for the last year

- Score lower than mean+1 standard deviation of global mean scores for young women on the EDE

- Fluent English speaker

- Former diagnosis of anorexia nervosa in relevant group

Exclusion Criteria:

- Any current diagnosis of a psychiatric disorder which in the investigator's opinion could impact study results (e.g. significant depression, anxiety or OCD).

- Any current psychotropic medications.

- Eyesight problems that would prohibit participating in a task-fMRI study.

- Current regular cigarette smoking of over 5 cigarettes per day.

- Recent use of illicit drugs.

- Alcohol intake which indicates an element of alcohol abuse; or unwillingness to refrain from drinking the night before the study visit.

- Any contraindications to MRI scanning (including claustrophobia).

- Participant is pregnant or breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI
MRI scan, including structural imaging, functional imaging (both task-related and structural), and Magnetic Resonance Spectroscopy.

Locations

Country Name City State
United Kingdom Department of Psychiatry, University of Oxford Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Boehm I, Geisler D, King JA, Ritschel F, Seidel M, Deza Araujo Y, Petermann J, Lohmeier H, Weiss J, Walter M, Roessner V, Ehrlich S. Increased resting state functional connectivity in the fronto-parietal and default mode network in anorexia nervosa. Front Behav Neurosci. 2014 Oct 2;8:346. doi: 10.3389/fnbeh.2014.00346. eCollection 2014. — View Citation

Chamberlain SR, Menzies L, Hampshire A, Suckling J, Fineberg NA, del Campo N, Aitken M, Craig K, Owen AM, Bullmore ET, Robbins TW, Sahakian BJ. Orbitofrontal dysfunction in patients with obsessive-compulsive disorder and their unaffected relatives. Science. 2008 Jul 18;321(5887):421-2. doi: 10.1126/science.1154433. — View Citation

Godlewska BR, Pike A, Sharpley AL, Ayton A, Park RJ, Cowen PJ, Emir UE. Brain glutamate in anorexia nervosa: a magnetic resonance spectroscopy case control study at 7 Tesla. Psychopharmacology (Berl). 2017 Feb;234(3):421-426. doi: 10.1007/s00213-016-4477-5. Epub 2016 Dec 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Oxygen-Level Dependent (BOLD) signal whilst performing set-shifting and reversal-learning BOLD signal differences between groups during the set-shifting and reversal-learning elements of a task: will be examined in orbitofrontal cortex, dorsolateral prefrontal cortex, and striatum. Analyse using a repeated measures ANOVA with region as within-subject factor and group as between-subject factor. Follow up significant interactions with paired t-tests. 1 day (During MRI scan)
Secondary Differences between groups in the connectivity of the fronto-parietal and default mode networks using independent components analysis, dual regression and permutation testing across the brain. A resting state scan will be performed, and an Independent Components Analysis will be performed to identify networks. Dual regression using fronto-parietal and default mode network to test whether there are group differences. This procedure regresses the group-spatial-maps into each subject's 4D dataset to give a set of timecourses, then regresses these timecourses into the same 4D dataset to get a subject-specific set of spatial maps. Then, the researchers will compare the spatial maps across groups of subjects to look for group differences in connectivity across the brain, using randomise permutation testing. 1 day (During MRI scan)
Secondary The correlation of the default mode network and frontoparietal network activity with perseverative errors on the Wisconsin Card Sorting Task across groups Correlate perseverative errors on Wisconsin Card Sorting Task with connectivity level of Default Mode Network (DMN) and frontoparietal network 1 day (During MRI scan)
Secondary Investigate a difference in levels of glutamate between groups Concentration of cortical glutamate in those who have recovered from anorexia relative to controls. Will be analysed using LCModel to quantify metabolites, then an independent samples t-test. 1 day (During MRI scan)
Secondary Examine differences between groups on an impulsivity measure Differences between scores on the Affective Go/No-Go Task. Analysed using a independent-samples t-test. 1 day (During MRI scan)
See also
  Status Clinical Trial Phase
Recruiting NCT00491478 - Repetitive Behavior Disorders in People With Severe Mental Retardation Phase 3
Completed NCT03265015 - Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study N/A
Completed NCT02794389 - Glutathione Levels and Compulsivity N/A
Completed NCT03067636 - Retraining Body and Brain to Conquer Compulsions N/A
Recruiting NCT04715256 - Evaluation of the Effects of KCNQ1 Mutation on Insulin Tolerance and Obsessive Compulsive Features in Long QT Romano-Ward Syndrome Patients. N/A
Recruiting NCT04580043 - Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors N/A