Fatigue Clinical Trial
Official title:
Cognitive Function and Fatigue After Brain Abscess
Verified date | February 2024 |
Source | University of Oslo |
Contact | Peder H Utne |
Phone | +4723066023 |
pedutn[@]ous-hf.no | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo | Oslo University Hospital, Sunnaas Rehabilitation Hospital |
Norway,
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
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. |
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