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NCT Number: NCT04938362

Cognitive Function and Fatigue After Brain Abscess

Brain abscess is a focal bacterial or fungal infection of the brain. Treatment is neurosurgical drainage of pus followed by long-term antibiotic treatment. In spite of successful treatment of the infection, long-term cognitive problems or mental fatigue may ensue. The reason for this dysfunction may be a continuing inflammatory state or damage to brain tissue caused by the abscess. The investigators will evaluate these possibilities with the use of [18F]deoxyglucose-positron emission tomography (FDG-PET) and electroencephalography (EEG) in patients who have been treated for brain abscess and who experience cognitive problems and/or fatigue. FDG-PET may identify both inflammation and altered neuronal activity (the latter indicating damage to brain tissue), and EEG may identify altered neuronal activity, including changes in neuronal network activity.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Brain abscess is a focal bacterial or fungal infection of the brain, which results in a pus-filled cavity within the brain parenchyma. The incidence is approximately 1/100 000 per year, and all age groups are affected. Treatment is neurosurgical drainage of pus followed by long-term antibiotic treatment. Previously, the capsule that surrounds the pus was removed surgically; this is not usually done anymore. In spite of successful treatment of the infection, patients may experience long-lasting cognitive problems or mental fatigue. The reason for this brain dysfunction is not known.

The investigators formulated two hypotheses to explain why some patients experience long-lasting cognitive problems and/or fatigue: 1) The brain abscess caused damage to brain tissue, interrupting neuronal networks underlying cognition or 2) The abscess or the remaining capsule causes a long-lasting inflammatory state of the brain, affecting neurotransmission and cerebral function.

In this prospective study, the investigators evaluate brain abscess patients by cognitive examination by a neuropsychologist at 2 and 12 months after treatment. Participants then undergo [18F]deoxyglucose-positron emission tomography (FDG-PET). An inflammatory state in the abscess area would be identified by the FDG-PET signal. Likewise, a change in neuronal (neocortical) function would be detectable from a change in the FDG-PET signal. Participants also undergo EEG investigation to establish whether fatigue is related to alterations in EEG parameters: alpha, theta, and delta activity.

Importantly, brain damage caused by the abscess may be irreversible and functional improvement of the patient would probably have to rely on compensatory strategies, whereas an inflammatory state could probably be modified by anti-inflammatory treatment.

Further, the prognosis for the patients' cognitive problems and fatigue is probably different if the underlying cause is inflammation rather than tissue damage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have completed treatment for brain abscess and who agree to participate.

Exclusion criteria

  • Patients who cannot undergo neuropsychological investigation due to unconsciousness
  • Patients who cannot undergo neuropsychological investigation, being mentally too ill
  • Patients who suffer from dementia
  • Patients who cannot undergo FDG-PET due to claustrophobia
  • Patients who cannot undergo EEG due to panic attacks
  • Age under 16.

Treatment and study plan

FDG-PET

Other

[18F]Deoxyglucose-positron emission tomography at 0-10 years after brain abscess

EEG

Other

Electroencephalography (EEG) at 0-10 years after brain abscess

Primary outcomes

  1. A change in FDG-PET signal indicating inflammation

    Time frame: When all patients have been followed up for at least 1 year.

    The FDG-PET signal indicates inflammation of brain tissue or the brain abscess capsule.

  2. A change in FDG-PET signal indicating a change in neuronal activity

    Time frame: When all patients have been followed up for at least 1 year.

    A change neocortical FDG-PET signal indicates a change in neuronal activity caused by brain tissue damage by the brain abscess.

  3. A change in EEG activity indicating a change in neuronal activity based on EEG power in alpha, theta, and delta frequencies.

    Time frame: When all patients have been followed up for at least 1 year.

    A change neocortical EEG activity indicates a change in neuronal activity caused by brain tissue damage by the brain abscess evident as changes in EEG power in alpha, theta, and delta frequencies..

Secondary outcomes

  1. Fatigue after brain abscess

    Time frame: When all patients have been followed up for at least 1 year.

    Neuropsychological investigation with the use of Chalder's fatigue questionnaire. Degree of fatigue is determined from the answers to 11 questions. The answer "Better than before" gives a score of 0, "Same as before" gives a score of 1, "Worse than before" gives a score of 2, and "Much worse than before" gives a score of 3. Thus, a maximum fatigue score is 33, meaning a very high degree of fatigue.

  2. No fatigue after brain abscess

    Time frame: When all patients have been followed up for at least 1 year.

    Neuropsychological investigation with the use of Chalder's fatigue questionnaire. Degree of fatigue is determined from the answers to 11 questions. The answer "Better than before" gives a score of 0, "Same as before" gives a score of 1, "Worse than before" gives a score of 2, and "Much worse than before" gives a score of 3. Thus, a maximum fatigue score is 33, meaning a very high degree of fatigue.

Study contacts

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

Peder H Utne

CONTACT

[email protected]

+4723066023

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • Sunnaas Rehabilitation Hospital

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jun 24, 2021
Registry last updated
Jul 4, 2025

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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