動脈瘤性くも膜下出血における海馬の体積と記憶機能
動脈瘤性くも膜下出血(aSAH)患者における海馬容積と記憶機能の関係の研究
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Melanie Boltzmann, PhD
- 電話番号:0049 5152 781 256
- メール:m.boltzmann@bdh-klinik-hessisch.oldendorf
研究連絡先のバックアップ
- 名前:Simone B Schmidt, PhD
- 電話番号:0049 5152 781 215
- メール:si.schmidt@bdh-klinik-hessisch.oldendorf
研究場所
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Hessisch Oldendorf、ドイツ、31840
- 募集
- BDH-Clinic Hessisch Oldendorf
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コンタクト:
- Melanie Boltzmann, PhD
- 電話番号:0049 5152 781 256
- メール:m.boltzmann@bdh-klinik-hessisch-oldendorf.de
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt & Hess grade I or II)
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:CASE_CONTROL
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changed hippocampal volume in aSAB
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changed memory function in aSAB
時間枠: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
時間枠: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
時間枠:2 weeks
|
Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes |
2 weeks
|
|
Interrater reliability
時間枠: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
時間枠:2 weeks
|
Hypothesis: patients have smaller intracranial volume than healthy control subjects. |
2 weeks
|
協力者と研究者
捜査官
- スタディディレクター:Jens D Rollnik, MD、BDH-Clinic Hessisch Oldendorf
- 主任研究者:Melanie Boltzmann, PhD、BDH-Clinic Hessisch Oldendorf
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SAB-VOL
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All IPD that underlie results in a publication.
IPD 共有時間枠
Period of availability begins when results are published, at the earliest in Dec 2022
IPD 共有アクセス基準
IPD can be obtained from the principal investigator upon reasonable request.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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