eural correlates of chronic fatigue syndrome

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

All subjects:
• >= 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);
• Scoring < 700 in the Sickness Impact Profile r_08 (SIPr08) total score;

Exclusion Criteria

• Infection or inflammation at the day of testing (Body temperature >= 38°C);
• 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, psycho-stimulants 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;

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>- Blood Oxygenation Level Dependent (BOLD) signal as measured with functional<br /><br>Magnetic Resonance Imaging (fMRI)<br /><br>- Cerebral tissue properties as measured with Magnetic Resonance Imaging (MRI)<br /><br>and Diffusion Tensor Imaging (DTI).<br /><br>- GABA and NAA concentration as determined by MR-spectroscopy<br /><br>- Behavioural performance on computerized tasks<br /><br>- Subjective measurements, e.g. self-report questionnaires, visual analogue<br /><br>scales<br /><br>- (Psycho) Physiological recordings e.g. surface electromyography (EMG)<br /><br>recordings, hart rate and respiration.<br /><br>- Cortisol and cytokine protein concentrations from hair, saliva and blood<br /><br>samples<br /><br>- Markers of sleep as measured with an ambulant electroencephalogram recording<br /><br>system</p><br>

Secondary Outcome Measures