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Clinical Trials/NCT04449666
NCT04449666
Recruiting
Not Applicable

Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)

BDH-Klinik Hessisch Oldendorf1 site in 1 country30 target enrollmentStarted: June 15, 2020Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
BDH-Klinik Hessisch Oldendorf
Enrollment
30
Locations
1
Primary Endpoint
Changed hippocampal volume in aSAB

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Influence of the lesion site on the hippocampal volume(2 weeks)
  • Changed intracranial volume in aSAB(2 weeks)
  • Changed memory function in aSAB(2 weeks)
  • Influence of the type of therapy on the hippocampal volume(2 weeks)
  • Interrater reliability(2 weeks)

Investigators

Sponsor
BDH-Klinik Hessisch Oldendorf
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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