NCT04938362

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) 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
57mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2020Dec 2030

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

11 years

First QC Date

June 13, 2021

Last Update Submit

July 1, 2025

Conditions

Brain AbscessFatigueCognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

  • A change in FDG-PET signal indicating inflammation

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

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

  • A change in FDG-PET signal indicating a change in neuronal activity

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

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

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

    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..

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

Secondary Outcomes (2)

  • Fatigue after brain abscess

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

  • No fatigue after brain abscess

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

Study Arms (2)

Brain abscess patients with cognitive dysfunction and/or fatigue

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

Other: FDG-PETOther: EEG

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-PETOther: EEG

Interventions

FDG-PETOTHER

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

Brain abscess patients with cognitive dysfunction and/or fatigueBrain abscess patients without cognitive dysfunction and/or fatigue
EEGOTHER

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

Brain abscess patients with cognitive dysfunction and/or fatigueBrain abscess patients without cognitive dysfunction and/or fatigue

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 16 years, who have completed treatment for brain abscess and who agree to participate.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

RECRUITING

Related Publications (4)

  • Rogne AG, Muller EG, Udnaes E, Sigurdardottir S, Raudeberg R, Connelly JP, Revheim ME, Hassel B, Dahlberg D. beta-Amyloid may accumulate in the human brain after focal bacterial infection: An 18 F-flutemetamol positron emission tomography study. Eur J Neurol. 2021 Mar;28(3):877-883. doi: 10.1111/ene.14622. Epub 2020 Nov 27.

    PMID: 33131195BACKGROUND

  • Dahlberg D, Holm S, Sagen EML, Michelsen AE, Stensland M, de Souza GA, Muller EG, Connelly JP, Revheim ME, Halvorsen B, Hassel B. Bacterial Brain Abscesses Expand Despite Effective Antibiotic Treatment: A Process Powered by Osmosis Due to Neutrophil Cell Death. Neurosurgery. 2023 Dec 12;94(5):1079-87. doi: 10.1227/neu.0000000000002792. Online ahead of print.

    PMID: 38084989BACKGROUND

  • Hassel B, Niehusmann P, Halvorsen B, Dahlberg D. Pro-inflammatory cytokines in cystic glioblastoma: A quantitative study with a comparison with bacterial brain abscesses. With an MRI investigation of displacement and destruction of the brain tissue surrounding a glioblastoma. Front Oncol. 2022 Jul 29;12:846674. doi: 10.3389/fonc.2022.846674. eCollection 2022.

    PMID: 35965529BACKGROUND

  • Muller EG, Dahlberg D, Hassel B, Revheim ME, Connelly JP. Brain Abscess Causes Brain Damage With Long-Lasting Focal Cerebral Hypoactivity that Correlates With Abscess Size: A Cross-Sectional 18 F-Fluoro-Deoxyglucose Positron Emission Tomography Study. Neurosurgery. 2024 Nov 11;97(1):138-147. doi: 10.1227/neu.0000000000003268.

    PMID: 39526777DERIVED

MeSH Terms

Conditions

Brain AbscessFatigueCognitive Dysfunction

Condition Hierarchy (Ancestors)

Central Nervous System InfectionsInfectionsAbscessSuppurationBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Bjørnar Hassel, MD, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Daniel Dahlberg, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peder H Utne

CONTACT

+4723066023pedutn@ous-hf.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 24, 2021

Study Start

January 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Patient data will be published on a group basis without identifiable characteristics. Publication will be in an international, peer-reviewed medical journal.

Locations

NO(1)