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动脉瘤性蛛网膜下腔出血的海马体积和记忆功能

2026年9月29日 更新者:BDH-Klinik Hessisch Oldendorf

动脉瘤性蛛网膜下腔出血(aSAH)患者海马体积与记忆功能关系的研究

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt & Hess grade I or II)

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • insufficient cardiorespiratory stability
  • previous brain damage
  • mental disorders (dementia, depression)
  • colonization with multi-resistant pathogens
  • MRI contraindications
  • claustrophobia
  • weight > 120 kg

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Experimental group

Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage

Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.

Control group

Healthy adults controlled for age, gender and educational status

Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changed hippocampal volume in aSAB
大体时间:2 weeks

Hypothesis: patients have smaller hippocampal volume than healthy control subjects. For the hippocampal volume a structural MRI scan (3D-MPRAGE) is obtained

2 weeks

次要结果测量

结果测量
措施说明
大体时间
Changed memory function in aSAB
大体时间:2 weeks

Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects.

2 weeks
Influence of the type of therapy on the hippocampal volume
大体时间:2 weeks

Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.

2 weeks
Influence of the lesion site on the hippocampal volume
大体时间:2 weeks

Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes

2 weeks
Interrater reliability
大体时间:2 weeks

Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters.

2 weeks
Changed intracranial volume in aSAB
大体时间:2 weeks

Hypothesis: patients have smaller intracranial volume than healthy control subjects.

2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Jens D Rollnik, MD、BDH-Clinic Hessisch Oldendorf
  • 首席研究员:Melanie Boltzmann, PhD、BDH-Clinic Hessisch Oldendorf

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月15日

初级完成 (估计的)

2030年6月15日

研究完成 (估计的)

2030年12月15日

研究注册日期

首次提交

2020年6月18日

首先提交符合 QC 标准的

2020年6月23日

首次发布 (实际的)

2020年6月29日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • SAB-VOL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All IPD that underlie results in a publication.

IPD 共享时间框架

Period of availability begins when results are published, at the earliest in Dec 2022

IPD 共享访问标准

IPD can be obtained from the principal investigator upon reasonable request.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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