Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Neuropsychological assessment and structural MRI.
- Кому может быть актуально
- Состояния в реестре: Neurologic Disorder, Subarachnoid Hemorrhage, Aneurysmal. Базовые параметры: 18 лет — 70 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
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)
Обзор
Neuropsychological and functional long-term consequences of subarachnoid hemorrhages (SAH) represent a great challenge, since sometimes considerable cognitive deficits occur without evidence of substantial brain damage. In this study, we want to examine if the frequently observed memory deficits are associated with hippocampal atrophy.
Подробное описание
Long-term or even permanent neuropsychological impairments are frequently observed after aneurysmal subarachnoid hemorrhages (aSAH). Among the most common impairments after aSAH are memory deficits. Volumetric MRI studies suggest an association of memory dysfunctions with temporal atrophy, especially of the hippocampus. In a previous study, 77 patients with good or moderate clinical outcome after aSAH were examined one year after discharge (Bendel et al., 2006). Temporomesial atrophy was detected without direct brain damage, e.g. by secondary ischemia. Due to the effects of complex cognitive impairments on the quality of life and participation in social and professional life, this relationship will be examined in more detail in the planned study. Specifically, we will investigate to what extent the frequently observed discrepancy between severe memory impairment and normal structural imaging results (no focal lesions in temporomesial areas) is due to hippocampal atrophy. In contrast to Bender and colleagues, this question will be investigated in the acute phase of the disease, immediately after admission to inpatient neurological rehabilitation.
Over a period of 24 months, 29 neurological rehabilitation patients with aSAH (Hunt \& Hess grade I and II) are going to be included. Within the first week (day 1 to 7) after study enrollment, a native MRI examination (without contrast agent) is performed, in which a high-resolution 3D-MPRAGE sequence (T1 weighting) is measured in the sagittal plane. After checking the data quality of the 3D-MPRAGE sequence, especially with regard to its suitability for hippocampal volume determination, a comprehensive neuropsychological examination is performed, in which specific memory and attentional functions are tested.
Вмешательства
- Диагностический тест Neuropsychological assessment and structural MRI
Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.
Первичные конечные точки
- Changed hippocampal volume in aSAB [Срок оценки: 2 weeks]
Вторичные конечные точки (5)
- Changed memory function in aSAB [Срок оценки: 2 weeks]
- Influence of the type of therapy on the hippocampal volume [Срок оценки: 2 weeks]
- Influence of the lesion site on the hippocampal volume [Срок оценки: 2 weeks]
- Interrater reliability [Срок оценки: 2 weeks]
- Changed intracranial volume in aSAB [Срок оценки: 2 weeks]
Критерии участия
Критерии включения
- neurological rehabilitation patients in phase B - D
- at minimum eight weeks after disease onset
- aneurysmal subarachnoid hemorrhage (Hunt \& Hess grade I or II)
- written consent from the patient's legal representative
- exclusion of pregnancy
Критерии исключения
- insufficient cardiorespiratory stability
- previous brain damage
- mental disorders (dementia, depression)
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight > 120 kg
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Германия · 1 центр
- BDH-Clinic Hessisch Oldendorf — Hessisch Oldendorf
Публикации
- Bendel P, Koivisto T, Hanninen T, Kolehmainen A, Kononen M, Hurskainen H, Pennanen C, Vanninen R. Subarachnoid hemorrhage is followed by temporomesial volume loss: MRI volumetric study. Neurology. 2006 Aug 22;67(4):575-82. doi: 10.1212/01.wnl.0000230221.95670.bf. PMID 16924007
Идентификаторы
NCT: NCT04449666 · SAB-VOL