Cognitive Function and Fatigue After Brain Abscess
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity of Oslo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Patients older than 16 years, who have completed treatment for brain abscess and who agree to participate.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
FDG-PET
Other intervention\[18F\]Deoxyglucose-positron emission tomography at 0-10 years after brain abscess
EEG
Other interventionElectroencephalography (EEG) at 0-10 years after brain abscess
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Brain abscess patients with cognitive dysfunction and/or fatigue2 interventions
Group B: Brain abscess patients without cognitive dysfunction and/or fatigue2 interventions
Trial outcomes
Primary outcomes
1
A change in FDG-PET signal indicating inflammation
The FDG-PET signal indicates inflammation of brain tissue or the brain abscess capsule.
Time frame
When all patients have been followed up for at least 1 year.2
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.
Time frame
When all patients have been followed up for at least 1 year.3
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..
Time frame
When all patients have been followed up for at least 1 year.Secondary outcomes
1
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.
Time frame
When all patients have been followed up for at least 1 year.2
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.
Time frame
When all patients have been followed up for at least 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oslo
Lead sponsor
Oslo University Hospital
Collaborator
Sunnaas Rehabilitation Hospital
Collaborator
Source ClinicalTrials.gov