Clinical trial NCT04449666: Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage
Official title: Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurologic Disorder
Subarachnoid Hemorrhage, Aneurysmal
Keywords: Neurological rehabilitation
Hippocampal volume
Memory deficits
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt \& Hess grade I or II)

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.

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.

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

Primary outcomes:
measure: Changed hippocampal volume in aSAB
timeFrame: 2 weeks
Secondary outcomes:
measure: Changed memory function in aSAB
timeFrame: 2 weeks
measure: Influence of the type of therapy on the hippocampal volume
timeFrame: 2 weeks
measure: Influence of the lesion site on the hippocampal volume
timeFrame: 2 weeks
measure: Interrater reliability
timeFrame: 2 weeks
measure: Changed intracranial volume in aSAB
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hessisch Oldendorf
country: Germany
facility: BDH-Clinic Hessisch Oldendorf
Study officials:
affiliation: BDH-Clinic Hessisch Oldendorf
name: Jens D Rollnik, MD
role: STUDY_DIRECTOR
affiliation: BDH-Clinic Hessisch Oldendorf
name: Melanie Boltzmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.