Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Disorder; Subarachnoid Hemorrhage, Aneurysmal
• Intervention / Treatment: Diagnostic test: Neuropsychological assessment and structural MRI

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Melanie Boltzmann, PhD; Phone Number: 0049 5152 781 256; Email: m.boltzmann@bdh-klinik-hessisch.oldendorf
• Study Contact Backup: Name: Simone B Schmidt, PhD; Phone Number: 0049 5152 781 215; Email: si.schmidt@bdh-klinik-hessisch.oldendorf

Study Locations

• Germany
  • Hessisch Oldendorf, Germany, 31840
    • Recruiting
    • BDH-Clinic Hessisch Oldendorf
    • Contact: Melanie Boltzmann, PhD; Phone Number: 0049 5152 781 256; Email: m.boltzmann@bdh-klinik-hessisch-oldendorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage	Diagnostic test: Neuropsychological assessment and structural MRI; 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	Diagnostic test: Neuropsychological assessment and structural MRI; Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed memory function in aSAB	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	Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.	2 weeks
Influence of the lesion site on the hippocampal volume	Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes	2 weeks
Interrater reliability	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	Hypothesis: patients have smaller intracranial volume than healthy control subjects.	2 weeks

Collaborators and Investigators

• Sponsor: BDH-Klinik Hessisch Oldendorf
• Investigators: Study Director: Jens D Rollnik, MD, BDH-Clinic Hessisch Oldendorf; Principal Investigator: Melanie Boltzmann, PhD, BDH-Clinic Hessisch Oldendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hippocampal volume; Neurological rehabilitation; Memory deficits
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Nervous System Diseases; Subarachnoid Hemorrhage
• Other Study ID Numbers: SAB-VOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication.
• IPD Sharing Time Frame: Period of availability begins when results are published, at the earliest in Dec 2022
• IPD Sharing Access Criteria: IPD can be obtained from the principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No