Role glymphotického systému avaluated thourgh MR zobrazení v diagnostice a léčbě NPH (GLINFANPH_2021)
9. února 2026 aktualizováno: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Cílem této observační studie je vyhodnotit roli DTI-ALP v diagnostickém a terapeutickém řízení NPH
Hlavní otázky, na které je třeba odpovědět, jsou:
- Zda je glymphatický systém (GS) ve skutečnosti narušen v NPH
- Zda index DTI-ALPS může předpovídat pozitivní odpověď na test TAP (TT) a na chirurgii ventrikulo-peritoneální zkratu (VPS).
Zdravá kontrolní skupina pacientů (HC Group) odpovídala věku se studijní skupinou, podstoupí MR se studií DTI-ALPS
Přehled studie
Postavení
Dokončeno
Detailní popis
Zapsaní pacienti sledovali diagnostickou terapeutickou cestu, sestávající z následujících kroků:
- T0: MR se studií DTI-ALPS;
- T1 (do 7 dnů od T0): Klinické a neurochirurgické hodnocení s NPH-specifickými ratingovými stupnicemi (podrobně uvedeno níže) před a po bederní TT, včetně měření tlaku otevíracího tlaku, drenáž 40-50 ml CSF a sběr vzorků pro neurodegenerativní biomarkery (β-amloid 42 a p-tau). MR s studií DTI-ALPS do 6 hodin od TT;
- T2 (do 3 měsíců od T1): Pacienti s pozitivní odpovědí TT (zahrnuli respondenti, IR skupina) podstoupili operaci VPS, se vzorky CSF odebraných pro stejné neurodegenerativní biomarkery (β-amyloid 40, 42 celkem a p-tau);
- T3 (tři měsíce po chirurgickém zákroku, pouze IR skupina): Klinické a neurochirurgické hodnocení pomocí stupnic specifických hodnocení NPH pro klasifikaci pacientů jako zlepšené, nezměněné nebo zhoršené ve srovnání s jejich předoperačním stavem; MR se studiem DTI-ALPS.
Typ studie
Pozorovací
Zápis (Aktuální)
29
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Milan, Itálie, 20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Pacienti postižení normálním tlakem hydrocefalus
Popis
Podezření na pacienty s NPH podle následujících:
Kritéria pro zařazení:
- Klinická a radiologická diagnostika pravděpodobné NPH podle existujících pokynů
- Věk přes 50 let
Kritéria pro vyloučení:
- neschopnost podstoupit MR
- Diagnóza jakékoli jiné neurologické patologie, zejména neurodegenerativní nebo neuroinflamační
- Předchozí neurochirurgické intervence na mozku jakéhokoli typu.
- neschopnost podstoupit obecnou anestézii
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Studijní skupina
Pacienti navštěvující ambulantní kliniku NPH byli do studie prospektivně zapsáni.
Kritéria pro zařazení byla: (i) klinická a radiologická diagnostika pravděpodobné NPH podle existujících pokynů a ii) věku více než 50 let.
Kritéria vyloučení byla: (i) neschopnost podstoupit MR; ii) diagnóza jakékoli jiné neurologické patologie, zejména neurodegenerativní nebo neuroinflamační; iii) předchozí neurochirurgické intervence na mozku jakéhokoli typu; (iv) Neschopnost podstoupit celkovou anestézii.
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Kontrolní skupina
Zdravá kontrolní skupina pacientů (HC Group) se shodovala s věkem se skupinou IR, podstoupila MR se studií DTI-ALPS.
Kritéria vyloučení pro tuto skupinu byly: (i) předchozí diagnóza jakékoli neurologické poruchy jakéhokoli typu.
ii) historie neurochirurgického zásahu jakéhokoli druhu; a (iii) předchozí diagnóza malignity jakéhokoli typu.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Srovnání studijní a kontrolní skupiny
Časové okno: 4 roky
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Rozdíl v indexu DTI Alps mezi pacienty NPH a zdravými kontrolami
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4 roky
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Rozdíl v odpovědi na tap test mezi pacienty s NPH, kteří reagovali, a těmi, kteří nereagovali
Časové okno: 4 roky
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Rozdíl v indexu DTI ALPS mezi pacienty s NPH, kteří reagovali na tap test (a podstoupili ventrikuloperitoneální shunt), a těmi, kteří nereagovali
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4 roky
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Změna indexu DTI ALPS během léčby u pacientů s NPH
Časové okno: 4 roky
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Rozdíl v indexu DTI ALPS u pacientů s NPH mezi T0 (před TT), T1 (po TT) a T3 (po VP shunt)
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4 roky
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Změna koncentrací degenerativních biomarkerů v mozkomíšním moku
Časové okno: 4 roky
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CSF degenerativní biomarkery (celkový tau protein, p-181 tau protein, protein Aβ42 a protein Aβ40) variace mezi T1, T2 a T3
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4 roky
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Morgan A Broggi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
15. června 2021
Primární dokončení (Aktuální)
31. srpna 2024
Dokončení studie (Aktuální)
31. prosince 2024
Termíny zápisu do studia
První předloženo
26. února 2025
První předloženo, které splnilo kritéria kontroly kvality
26. února 2025
První zveřejněno (Aktuální)
4. března 2025
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. února 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. února 2026
Naposledy ověřeno
1. února 2025
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GLINFANPH_2021
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .