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Neural correlates of chronic fatigue syndrome


- candidate number15852
- NTR NumberNTR4311
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2013
- Secondary IDs2013/113 CCMO Arnhem/Nijmegen
- Public TitleNeural correlates of chronic fatigue syndrome
- Scientific TitleNeural correlates of chronic fatigue syndrome
- ACRONYMCFS and the brain
- hypothesisThe primary objectives of this project are:
- Identify neural correlates and behavioural measures that underlie cognitive processes that perpetuate CFS symptoms
- Identify neural mechanisms of change that mediate successful CBT.
- Healt Condition(s) or Problem(s) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteria ≥ 18 years ≤ 50 years;
Women;
Able to speak read and write Dutch;
Predominantly right handedness;
Give written informed consent;
Patients:
Meet the 1994 US centre for Disease Control and Prevention criteria for Chronic Fatigue Syndrome (revised 2003)
Severely fatigued, i.e. scoring ≥ 40 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
Severely disabled; i.e scoring ≥ 700 in the Sickness Impact Profile r_08 (SIPr08) total score;
Healthy control:
Scoring ≤ 35 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
Scoring < 700 in the Sickness Impact Profile r_08 (SIPr08) total score;
- Exclusion criteria Any injury to the right hand that confounds hand grip performance;
A maximal voluntary contraction (MVC) that exceeds the maximal dispersion of the hand grip device (>400 Newton)
(History of) long term use of anti-depressants, anti-anxiety medications, beta-blockers benzodiazepines, psychostimulants or sleep medication;
Current major depressive or bipolar disorder
(History of) Schizophrenia or delusional disorder.
(History of) Anorexia nervosa or bulimia nervosa
(History of) alcohol or substance abuse
Severe obesity (BMI ≥ 40)
Abnormal hearing or (uncorrected) vision; MRI Contraindications:
Irremovable metal objects in or around the body (e.g. braces, pacemaker, metal fragments, hearing devices);
Claustrophobia;
(History of) Epilepsy;
Possible pregnancy or breastfeeding;
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants120
- InterventionsCognitive behavioural therapy versus waitinglist
- Primary outcome- Blood Oxygenation Level Dependent (BOLD) signal as measured with functional Magnetic Resonance Imaging (fMRI)
- Cerebral tissue properties as measured with Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging (DTI) and MR-spectroscopy.
- Behavioural performance on computerized tasks
- Fatigue severity: checklist individual strength (CIS)
- Secondary outcome- Subjective measurements, e.g. self-report questionnaires, visual analogue scales
- NAA concentration as determined by MR-spectroscopy
- Cortisol and cytokine protein concentrations from hair, saliva and blood samples
- TimepointsCFS patients will be tested before and after cognitive behavioral therapy or waiting list (6 months apart) and compared with healthy controls.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Marieke Schaaf, van der
- CONTACT for SCIENTIFIC QUERIES Marieke Schaaf, van der
- Sponsor/Initiator Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Private fund
- PublicationsN/A
- Brief summaryChronic fatigue syndrome (CFS) is characterized by profound disabling fatigue with an unknown aetiology. CFS is currently treated with cognitive behavioural therapy (CBT), which has proven to be a successful intervention leading to a reduction in fatigue and disability. Consistent with cognitive behavioural models of CFS, recent clinical research has shown that mainly cognitive factors mediate successful therapy outcome. Accordingly, with support from neuroimaging studies, it has been suggested that central (cognitive) mechanisms play a role in CFS and its treatment. This project aims at identifying the neural correlates of central mechanisms that perpetuate CFS symptoms and underlie the mechanisms of change of CBT. Our hypotheses are derived from a neurobiological hierarchical Bayesian model of medically unexplained symptoms (Edwards et al., 2012) that emphasizes the influence of dysfunctional beliefs on perception. According to this model, somatoform symptoms arise from an inference failure between prior beliefs and sensory evidence. Thus, it is hypothesized that fatigue-related beliefs may bias perception towards experiencing fatigue. This project aims at investigating neural correlates associated with inference processes that are thought to underlie CFS symptoms. In addition, we will assess how these mechanisms change during cognitive behavioural therapy.
- Main changes (audit trail)8-juni-2015: Change in inclusion criteria

NEW
Inclusion criteria:
≥ 18 years ≤ 65 years;
Women;
Able to speak read and write Dutch;
Predominantly right handedness;
Give written informed consent;
Patients:
Meet the 1994 US centre for Disease Control and Prevention criteria for Chronic Fatigue Syndrome (revised 2003)
Severely fatigued, i.e. scoring ≥ 40 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
Severely disabled; i.e scoring ≥ 700 in the Sickness Impact Profile r_08 (SIPr08) total score;
Healthy control:
Scoring ≤ 35 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
- RECORD9-dec-2013 - 28-jun-2016


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