Меню
Идёт набор NCT04938362

Cognitive Function and Fatigue After Brain Abscess

Наблюдательное Brain Abscess Fatigue Cognitive Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FDG-PET, EEG.
Кому может быть актуально
Состояния в реестре: Brain Abscess, Fatigue, Cognitive Dysfunction. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • A change in FDG-PET signal indicating inflammation [Срок оценки: When all patients have been followed up for at least 1 year.]
  • A change in FDG-PET signal indicating a change in neuronal activity [Срок оценки: 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. [Срок оценки: When all patients have been followed up for at least 1 year.]
Вторичные конечные точки (2)
  • Fatigue after brain abscess [Срок оценки: When all patients have been followed up for at least 1 year.]
  • No fatigue after brain abscess [Срок оценки: When all patients have been followed up for at least 1 year.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Норвегия · 1 центр
  • Oslo University Hospital — Oslo

Публикации

  • 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 33131195
  • 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. 2024 May 1;94(5):1079-1087. doi: 10.1227/neu.0000000000002792. Epub 2023 Dec 12. PMID 38084989
  • 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 35965529
  • 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 39526777

Идентификаторы

NCT: NCT04938362 · Cognition/fatigue/brainabscess

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗