Neural correlates of chronic fatigue syndrome

Neural correlates of chronic fatigue syndrome - Neural correlates of chronic fatigue syndrome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38461

Enrollment

160

Registered

2013-04-17

Start date

2014-01-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic fatigue

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All subjects: • >= 18 years = 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

Exclusion criteria

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;

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results