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临床试验/NCT04938362
NCT04938362招募中不适用

Cognitive Function and Fatigue After Brain Abscess

University of Oslo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
A change in FDG-PET signal indicating inflammation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

A change in FDG-PET signal indicating inflammation

时间窗: 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.

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

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

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..

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

时间窗: 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.

次要结局

  • No fatigue after brain abscess(When all patients have been followed up for at least 1 year.)
  • Fatigue after brain abscess(When all patients have been followed up for at least 1 year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjørnar Hassel

Professor

University of Oslo

研究点 (1)

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