Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

NCT04449666 | Recruiting

• 1 other identifier: SAB-VOL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder; Subarachnoid Hemorrhage, Aneurysmal

Keywords

Neurological rehabilitation; Hippocampal volume; Memory deficits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changed memory function in aSAB

  2 weeks

• Influence of the type of therapy on the hippocampal volume

  2 weeks

• Influence of the lesion site on the hippocampal volume

  2 weeks

• Interrater reliability

  2 weeks

• Changed intracranial volume in aSAB

  2 weeks

Study Arms (2)

Experimental group

Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage

Diagnostic Test: Neuropsychological assessment and structural MRI

Control group

Healthy adults controlled for age, gender and educational status

Diagnostic Test: Neuropsychological assessment and structural MRI

Interventions

Neuropsychological assessment and structural MRI DIAGNOSTIC_TEST

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, 31840, Germany

RECRUITING

Related 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.

  PMID: 16924007 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Subarachnoid Hemorrhage; Memory Disorders

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jens D Rollnik, MD

  BDH-Clinic Hessisch Oldendorf

  STUDY DIRECTOR

• Melanie Boltzmann, PhD

  BDH-Clinic Hessisch Oldendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Boltzmann, PhD

CONTACT

0049 5152 781 256; m.boltzmann@bdh-klinik-hessisch.oldendorf

Simone B Schmidt, PhD

CONTACT

0049 5152 781 215; si.schmidt@bdh-klinik-hessisch.oldendorf

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 29, 2020
• Study Start: June 15, 2020
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Period of availability begins when results are published, at the earliest in Dec 2022
• Access Criteria: IPD can be obtained from the principal investigator upon reasonable request.

Locations

DE (1)