跳至主要内容
临床试验/NCT04449666
NCT04449666招募中不适用

Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)

BDH-Klinik Hessisch Oldendorf1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Changed hippocampal volume in aSAB

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Changed hippocampal volume in aSAB

时间窗: 2 weeks

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

次要结局

  • Influence of the lesion site on the hippocampal volume(2 weeks)
  • Changed intracranial volume in aSAB(2 weeks)
  • Changed memory function in aSAB(2 weeks)
  • Influence of the type of therapy on the hippocampal volume(2 weeks)
  • Interrater reliability(2 weeks)

研究者

发起方
BDH-Klinik Hessisch Oldendorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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