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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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MRC CFS Autonomic Grant
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Understanding the pathogenesis of autonomic dysfunction in chronic fatigue syndrome (CFS) and its relationship with cognitive impairment
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Topic
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Generic Relevance & Cross Cutting Themes
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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EudraCT
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MREC N°
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UKCRN ID
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12398
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WHO ID
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Research Summary
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Chronic fatigue syndrome (CFS) occurs in 0.20.4% of the population and currently its cause is unclear. Abnormality of the autonomic nervous system is recognised in 3/4 of CFS sufferers and we believe that it underpins many of the symptoms that are characteristic of CFS. Autonomic nervous system dysfunction is characterised by symptoms of dizziness on standing, symptoms present in nearly 90% of people with CFS. Despite this, why autonomic dysfunction occurs in people with CFS is not understood and as a result treatments limited. This study will explore what leads to autonomic dysfunction in CFS particularly whether it occurs because of abnormalities in centres in the brain that control the autonomic nervous system, or, due to a peripheral volume or vascular problem. In non-CFS diseases, autonomic dysfunction has also been shown to be associated with memory and concentration problems (cognitive impairment). Over 80% of those with CFS describe problems with memory and concentration, so this study will also explore whether there is a relationship between autonomic dysfunction and cognitive problems.
The programme has two phases: 1) We will use new ground breaking brain magnetic resonance scans that will allow us to study brain function in CFS and how this relates to problems of blood pressure control (autonomic nervous system) and memory and concentration (cognitive function). 2) We will explore whether cardiac or blood vessel function might contribute to autonomic dysfunction in CFS.
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Study Type
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Observational
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Design Type
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Cross-sectional study
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Disease(s)
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Age and ageing
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Phase
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N/A
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Current Status
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Open
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Closure Date
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11/20/2015
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Global Sample Size
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81
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Global Recruitment to Date
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 25% |
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Geographical Scope
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Single Centre
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Lead Country
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England
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Open to new sites
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No
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Main Inclusion Criteria
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All CFS participants will have CFS as defined by the Fukuda criteria.
Subjects will complete the validated autonomic symptom assessment tool Composite Autonomic Symptom Scale.
This will allow the inclusion of four groups of subjects in the study work packages; three cohorts of patients with CFS (Fukuda) and a fourth group of sedentary controls drawn from the local population.
Autonomic phenotype will be determined using our recently defined autonomic diagnostic criteria, in this study those with an autonomic phenotype had a COMPASS score of >32.5 (mean + 2SD for the normal control population). The CFS cohorts will be 1) established CFS (symptoms for >3 years) with an autonomic phenotype 2) early / newly diagnosed CFS (symptoms for 6-8 months at the time of study) with an autonomic phenotype and 3) CFS without an autonomic phenotype.
Including the group with newly diagnosed disease will allow us to examine the chronicity of our findings, whether they are related to deconditioning and to begin to explore cause and effect.
The CFS autonomic phenotype will be matched to CFS without an autonomic phenotype for age, sex.
The control population will allow us to determine whether any changes we detect are specific to CFS or to an autonomic phenotype.
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Main Exclusion Criteria
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Unable to provide written informed consent.
Unable to travel for assessments.
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Chief Investigator(s)
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| Prof Julia Newton |
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Further details, please contact
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Prof Julia Newton
Newcastle Upon Tyne Hospitals NHS Trust and University of Newcastle Upon Tyne (Specialty – Ageing)
School of Medical SciencesMedical School
Framlington Place
Newcastle Upon Tyne
Tyne and Wear
NE2 4HH
UNITED KINGDOM
Tel: 0191 208 1362
julia.newton@ncl.ac.uk
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| Funder(s) |
Medical Research Council (MRC)
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| Sponsor(s) |
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