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NCT Number: NCT07394855

Mechanisms of Persistent Fatigue

Persistent fatigue (PF) is a common symptom across countries and cultures, and an important cause of disability and reduced quality of life. Acute infection is a common trigger of PF, as exemplified by the 'Long COVID' phenomenon. Despite substantial burden for the suffering individuals as well as their next-of-kins, the healthcare systems and the economy, PF is an under-researched field, with scarce knowledge of disease mechanisms as well as treatment and preventive measures.

Existing knowledge on PF suggests complex interactions between functional brain processes (as opposed to permanent brain damage), aberrations of the immune system (that normally protects against infection) and the autonomic (or non-voluntary) part of the nervous system (that monitors the internal state of the body and adjusts the function of internal organs). Previous findings have been interpreted in light of two alternative models: A body-to-brain mechanism where disturbances of the immune system are thought to impact on brain functions, and a brain-to-body mechanism where functional brain alteration is regarded the central element whereas aberration of the immune system is seen as a consequence (rather than a cause) mediated through altered activity of the autonomic nervous system.

The multinational and collaborative Mechanism of Persistent Fatigue (MAP-FAT) project is determined to scrutinize both these potential brain-body interactions in PF. The main objectives are: a) To determine the relationship between PF, activities in certain brain areas, activity in a certain part of the autonomic nervous system (the sympathetic branch), and immunological alterations; b) To determine whether PF is primarily dependent upon the brain's automatic predictions rather than the continuous sensory information mediated to the brain. To achieve these objectives, MAP-FAT will exploit an existing health registry on post-infective fatigue (preparatory part) and conduct a new post-infective cohort study (main part) in which a total of 150 individuals with "kissing disease" and 150 healthy controls are followed for six months. Investigations include: a) Clinical and demographic assessment; b) Questionnaire charting; c) Functional and structural imaging of the brain (multimodal brain MRI); d) Assessment of autonomic nervous system activity; e) Deep immunological profiling; and f) Behavioral experiments. The latter are specifically designed to disentangle the relative contributions of the brain's automatic predictions and sensory input for the experience of PF. In addition, one of the experiments includes concurrent functional brain imaging, autonomic nervous system assessment, and immunological profiling during experimental injections of drugs that impact on autonomic activity; this experiment is key for addressing the causal association between brain functions, autonomic activity and immunological disturbance.

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Key information

Conditions

Age range

16 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, N-1478, Norway

Location status: Recruiting

Location contact

Director of Dept. of Paeditrics and Adolescent Medicine

CONTACT

[email protected]

4767960000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(pertaining to EBV group only):

  • EBV infection, laboratory confirmed.
  • First symptoms > 3 and < 6 weeks away

Exclusion criteria

(pertaining to both groups)

  • Co-morbidity, including mental illness (seasonal allergy/asthma is accepted if no signs/symptoms)
  • Usage of pharmaceuticals (hormonal contraception and paracetamol/ibuprofen is accepted)
  • Concurrent demanding life event causing fatigue.
  • Disability impacting on daily living.
  • Regular smoking
  • Usage of illicit drugs
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. ASP difference

    Time frame: At six months' follow-up

    The difference in symptom ratings between neutral and negative affect provoking pictures during the Affect and Symptom Paradigm (ASP)

Secondary outcomes

  1. VHBP regression ratio

    Time frame: At six months' follow-up

    Ratio between the regression coefficient for exerted power vs. fatigue (an index of interoceptive input) and the regression coefficient for virtual hill gradient vs. fatigue (an index of prior expectations) during the Virtual Hill Bicycling Paradigm (VHBP)

  2. INSULA connectivity

    Time frame: At six months' follow-up

    Functional connectivity characteristics of the Insula cortical brain region

  3. FATIGUE CFQ

    Time frame: At six months' follow-up

    Fatigue scores (sum score from the Chalder Fatigue Questionnaire (CFQ), where higher values means more fatigue).

Study contacts

Contact information is provided by the study sponsor or research team.

Vegard Bruun Bratholm Wyller

CONTACT

[email protected]

+4791166681

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

Mechanisms of Persistent Fatigue (MAP-FAT): A Prospective Observational Cohort Study of Persistent Fatigue Following Epstein-Barr Virus Infection in Adolescents and Young Adults

Acronym: MAP-FAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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