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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)
- ClinicalTrials.gov ID
- NCT04449666
- Acronym / sponsor ID
- SAB-VOL
- Keywords
- Neurological rehabilitation, Hippocampal volume, Memory deficits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: Neuropsychological assessment and structural MRIPatients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage |
| Control group | – | Diagnostic Test: Neuropsychological assessment and structural MRIHealthy adults controlled for age, gender and educational status |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt \& Hess grade I or II)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- insufficient cardiorespiratory stability
- previous brain damage
- mental disorders (dementia, depression)
- colonization with multi-resistant pathogens
- MRI contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessment and structural MRIComplex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured. | Diagnostic test | Control group, Experimental group |
Primary outcome
Changed hippocampal volume in aSAB
Time frame: 2 weeks
Hypothesis: patients have smaller hippocampal volume than healthy control subjects. For the hippocampal volume a structural MRI scan (3D-MPRAGE) is obtained
5 secondary outcomes
Changed memory function in aSAB
Time frame: 2 weeks
Influence of the type of therapy on the hippocampal volume
Time frame: 2 weeks
Influence of the lesion site on the hippocampal volume
Time frame: 2 weeks
Interrater reliability
Time frame: 2 weeks
Changed intracranial volume in aSAB
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 16924007Bendel 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens D Rollnik, MD study director
BDH-Clinic Hessisch Oldendorf
Melanie Boltzmann, PhD principal investigator
BDH-Clinic Hessisch Oldendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Subarachnoid Hemorrhage, Aneurysmal, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Boltzmann, PhD (0049 5152 781 256, m.boltzmann@bdh-klinik-hessisch.oldendorf), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed hippocampal volume in aSAB (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.