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RecruitingNCT04449666Updated Sep 19, 2025

Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

An observational study in Neurologic Disorder and Subarachnoid Hemorrhage, Aneurysmal, sponsored by BDH-Klinik Hessisch Oldendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by BDH-Klinik Hessisch Oldendorf · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neurologic Disorder
  • Subarachnoid Hemorrhage, Aneurysmal

Keywords

  • Neurological rehabilitation
  • Hippocampal volume
  • Memory deficits
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testNeuropsychological assessment and structural MRI

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

05

What researchers measure

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

    Time frame: 2 weeks

Secondary outcomes

  1. Changed memory function in aSAB

    Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects.

    Time frame: 2 weeks

  2. Influence of the type of therapy on the hippocampal volume

    Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.

    Time frame: 2 weeks

  3. Influence of the lesion site on the hippocampal volume

    Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes

    Time frame: 2 weeks

  4. Interrater reliability

    Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters.

    Time frame: 2 weeks

  5. Changed intracranial volume in aSAB

    Hypothesis: patients have smaller intracranial volume than healthy control subjects.

    Time frame: 2 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

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. PubMed 16924007 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT04449666
Lead sponsor
BDH-Klinik Hessisch Oldendorf
Responsible party
Sponsor
First posted
Jun 29, 2020
Start date
Jun 15, 2020
Primary completion
Jun 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Melanie Boltzmann, PhD
Contact
m.boltzmann@bdh-klinik-hessisch.oldendorf
0049 5152 781 256
Simone B Schmidt, PhD
Contact
si.schmidt@bdh-klinik-hessisch.oldendorf
0049 5152 781 215
Jens D Rollnik, MD
study director · BDH-Clinic Hessisch Oldendorf
Melanie Boltzmann, PhD
principal investigator · BDH-Clinic Hessisch Oldendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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