Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT04449666

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2026-12-15

Brief 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.

Detailed 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.

Conditions

Neurologic Disorder; Subarachnoid Hemorrhage, Aneurysmal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group

Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage

Neuropsychological assessment and structural MRI

Intervention Type: DIAGNOSTIC_TEST

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

Neuropsychological assessment and structural MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Neuropsychological assessment and structural MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BDH-Klinik Hessisch Oldendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens D Rollnik, MD

Role: STUDY_DIRECTOR

BDH-Clinic Hessisch Oldendorf

Melanie Boltzmann, PhD

Role: PRINCIPAL_INVESTIGATOR

BDH-Clinic Hessisch Oldendorf

Locations

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Melanie Boltzmann, PhD

Role: CONTACT

m.boltzmann@bdh-klinik-hessisch.oldendorf

0049 5152 781 256

Simone B Schmidt, PhD

Role: CONTACT

si.schmidt@bdh-klinik-hessisch.oldendorf

0049 5152 781 215

Facility Contacts

Melanie Boltzmann, PhD

Role: primary

m.boltzmann@bdh-klinik-hessisch-oldendorf.de

0049 5152 781 256

References

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.

Reference Type: BACKGROUND

PMID: 16924007 (View on PubMed)

Other Identifiers

SAB-VOL

Identifier Type: -

Identifier Source: org_study_id