Cognitive Function and Fatigue After Brain Abscess

Fatigue Clinical Trial

Official title:

Cognitive Function and Fatigue After Brain Abscess

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938362
• Other study ID #: Cognition/fatigue/brainabscess
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: University of Oslo
• Contact: Peder H Utne
• Phone: +4723066023
• Email: pedutn[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• Brain Abscess
• Cognitive Dysfunction
• Fatigue

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, Sunnaas Rehabilitation Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. doi: 10.1227/neu.0000000000002792. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Fatigue after brain abscess	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.	When all patients have been followed up for at least 1 year.
Secondary	No fatigue after brain abscess	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.	When all patients have been followed up for at least 1 year.