- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04449666
Hippocampus volum og minnefunksjoner i aneurysmal subaraknoidal blødning
Undersøkelse av forholdet mellom hippocampusvolum og hukommelsesfunksjoner hos pasienter med aneurysmal subaraknoidalblødning (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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Melanie Boltzmann, PhD
- Telefonnummer: 0049 5152 781 256
- E-post: m.boltzmann@bdh-klinik-hessisch.oldendorf
Studer Kontakt Backup
- Navn: Simone B Schmidt, PhD
- Telefonnummer: 0049 5152 781 215
- E-post: si.schmidt@bdh-klinik-hessisch.oldendorf
Studiesteder
-
-
-
Hessisch Oldendorf, Tyskland, 31840
- Rekruttering
- BDH-Clinic Hessisch Oldendorf
-
Ta kontakt med:
- Melanie Boltzmann, PhD
- Telefonnummer: 0049 5152 781 256
- E-post: m.boltzmann@bdh-klinik-hessisch-oldendorf.de
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt & Hess grade I or II)
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Experimental group
Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage |
Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured. |
|
Control group
Healthy adults controlled for age, gender and educational status |
Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changed hippocampal volume in aSAB
Tidsramme: 2 weeks
|
Hypothesis: patients have smaller hippocampal volume than healthy control subjects. For the hippocampal volume a structural MRI scan (3D-MPRAGE) is obtained |
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changed memory function in aSAB
Tidsramme: 2 weeks
|
Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects. |
2 weeks
|
|
Influence of the type of therapy on the hippocampal volume
Tidsramme: 2 weeks
|
Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment. |
2 weeks
|
|
Influence of the lesion site on the hippocampal volume
Tidsramme: 2 weeks
|
Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes |
2 weeks
|
|
Interrater reliability
Tidsramme: 2 weeks
|
Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters. |
2 weeks
|
|
Changed intracranial volume in aSAB
Tidsramme: 2 weeks
|
Hypothesis: patients have smaller intracranial volume than healthy control subjects. |
2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Jens D Rollnik, MD, BDH-Clinic Hessisch Oldendorf
- Hovedetterforsker: Melanie Boltzmann, PhD, BDH-Clinic Hessisch Oldendorf
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Nevroatferdsmanifestasjoner
- Blødning
- Intrakranielle blødninger
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Sykdommer i nervesystemet
- Hjernehinneblødning
- Minneforstyrrelser
Andre studie-ID-numre
- SAB-VOL
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
All IPD that underlie results in a publication.
IPD-delingstidsramme
Period of availability begins when results are published, at the earliest in Dec 2022
Tilgangskriterier for IPD-deling
IPD can be obtained from the principal investigator upon reasonable request.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .