Cognitive Function and Fatigue After Brain Abscess

Sponsor
University of Oslo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04938362
Collaborator
Oslo University Hospital (Other), Sunnaas Rehabilitation Hospital (Other)
50
1
132
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Study Details

Study Description

Brief Summary

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) 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).

Condition or Disease Intervention/Treatment Phase
  • Other: FDG-PET

Detailed Description

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.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cognitive Function and Fatigue After Brain Abscess
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
Brain abscess patients with cognitive dysfunction and/or fatigue

This group of patients experience cognitive dysfunction and/or fatigue after brain abscess.

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

Brain abscess patients without cognitive dysfunction and/or fatigue

This group of patients does not experience cognitive dysfunction and/or fatigue after brain abscess.

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

Outcome Measures

Primary Outcome Measures

  1. A change in FDG-PET signal indicating inflammation [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 [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.

Secondary Outcome Measures

  1. Fatigue after brain abscess [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Age under 16.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0450

Sponsors and Collaborators

  • University of Oslo
  • Oslo University Hospital
  • Sunnaas Rehabilitation Hospital

Investigators

  • Principal Investigator: Bjørnar Hassel, MD, PhD, University of Oslo
  • Principal Investigator: Daniel Dahlberg, MD, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bjørnar Hassel, Professor, University of Oslo
ClinicalTrials.gov Identifier:
NCT04938362
Other Study ID Numbers:
  • Cognition/fatigue/brainabscess
First Posted:
Jun 24, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021