Neurologic DisorderNCT04449666
Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage
An observational study of Neurologic Disorder and Subarachnoid Hemorrhage, Aneurysmal, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neurologic Disorder, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Neuropsychological assessment and structural MRI
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2020to 15 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt \& Hess grade I or II)
Who may be able to join
- 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
Who cannot join
- insufficient cardiorespiratory stability
- previous brain damage
- mental disorders (dementia, depression)
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight > 120 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, 31840
Melanie Boltzmann, PhD, 0049 5152 781 256, m.boltzmann@bdh-klinik-hessisch-oldendorf.de
About this study
Official title: 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.
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.
- Being tested
- Neuropsychological assessment and structural MRI
- Keywords
- Neurological rehabilitation, Hippocampal volume, Memory deficits
- Medical subject headings
- Nervous System Diseases, Subarachnoid Hemorrhage, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessment and structural MRIDiagnostic test
Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage Receives: Diagnostic Test: Neuropsychological assessment and structural MRI | |
| Control group | Healthy adults controlled for age, gender and educational status Receives: Diagnostic Test: Neuropsychological assessment and structural MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (5)
Changed memory function in aSAB
Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects.
Measured: 2 weeks
Influence of the type of therapy on the hippocampal volume
Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.
Measured: 2 weeks
Influence of the lesion site on the hippocampal volume
Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes
Measured: 2 weeks
Interrater reliability
Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters.
Measured: 2 weeks
Changed intracranial volume in aSAB
Hypothesis: patients have smaller intracranial volume than healthy control subjects.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens D Rollnik, MD, Study director, BDH-Clinic Hessisch OldendorfMelanie Boltzmann, PhD, Principal investigator, BDH-Clinic Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449666
- Sponsor's protocol ID
- SAB-VOL
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
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