Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

Neurologic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449666
• Other study ID #: SAB-VOL
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: December 15, 2024

Study information

• Verified date: August 2023
• Source: BDH-Klinik Hessisch Oldendorf
• Contact: Melanie Boltzmann, PhD
• Phone: 0049 5152 781 256
• Email: m.boltzmann[@]bdh-klinik-hessisch.oldendorf
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Nervous System Diseases
• Neurologic Disorder
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Diagnostic Test:
• Neuropsychological assessment and structural MRI
Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.

Locations

Country	Name	City	State
Germany	BDH-Clinic Hessisch Oldendorf	Hessisch Oldendorf

Sponsors (1)

Lead Sponsor	Collaborator
BDH-Klinik Hessisch Oldendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changed hippocampal volume in aSAB	Hypothesis: patients have smaller hippocampal volume than healthy control subjects. For the hippocampal volume a structural MRI scan (3D-MPRAGE) is obtained	2 weeks
Secondary	Changed memory function in aSAB	Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects.	2 weeks
Secondary	Influence of the type of therapy on the hippocampal volume	Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.	2 weeks
Secondary	Influence of the lesion site on the hippocampal volume	Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes	2 weeks
Secondary	Interrater reliability	Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters.	2 weeks
Secondary	Changed intracranial volume in aSAB	Hypothesis: patients have smaller intracranial volume than healthy control subjects.	2 weeks