Rola układu glimfatycznego z obrazowaniem MR w diagnozie i leczeniu NPH (GLINFANPH_2021)
9 lutego 2026 zaktualizowane przez: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Celem tego badania obserwacyjnego jest ocena roli DTI-AlP w zarządzaniu diagnostycznym i terapeutycznym NPH
Główne pytania, na które ma na celu odpowiedzieć::
- Czy system glimfatyczny (GS) jest faktycznie upośledzony w NPH
- Czy wskaźnik DTI-Alps może przewidzieć pozytywną odpowiedź na test TAT (TT) i operację bocznikowego (VPS).
Zdrowa grupa kontrolna pacjentów (grupa HC) dopasowana do wieku do grupy badanej, ulegnie MR z badaniem DTI-ALPS
Przegląd badań
Status
Zakończony
Szczegółowy opis
Zapisani pacjenci przestrzegali szlaku diagnostycznego-terapeutycznego, polegającego na następujących krokach:
- T0: MR z badaniem DTI-Alps;
- T1 (w ciągu 7 dni od T0): Ocena kliniczna i neurochirurgiczna ze specyficznymi dla NPH skal oceny (szczegółowo poniżej) przed i po lędźwiowym TT, w tym pomiary ciśnienia otwierającego, drenaż 40-50 ml CSF i pobieranie próbek dla biomarkerów neurodegeneracyjnych (β-amyloid 40, 42, 42, 42, 42, 42, 42, 42. MR z badaniem DTI-Alps w ciągu 6 godzin od TT;
- T2 (w ciągu 3 miesięcy od T1): Pacjenci z dodatnią odpowiedź TT (w tym respondenci, grupa IR) przeszli operację VPS, z próbkami CSF zebranymi dla tych samych biomarkerów neurodegeneracyjnych (β-amyloid 40, 42 Total i P-Tau);
- T3 (trzy miesiące po zabiegu, tylko grupa IR): Ocena kliniczna i neurochirurgiczna z wykorzystaniem skal ratingowych specyficznych dla NPH w celu sklasyfikowania pacjentów jako ulepszonych, niezmienionych lub pogarszających się w porównaniu z ich stanem przedoperacyjnym; MR z badaniem DTI-Alps.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
29
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Milan, Włochy, 20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Pacjenci dotknięci normalnym wodogłowiem
Opis
Podejrzewane pacjentów z NPH zgodnie z następującymi:
Kryteria włączenia:
- Diagnoza kliniczna i radiologiczna prawdopodobnego NPH zgodnie z istniejącymi wytycznymi
- Wiek ponad 50 lat
Kryteria wykluczenia:
- Niemożność poddania się MR
- Diagnoza jakiejkolwiek innej patologii neurologicznej, szczególnie neurodegeneracyjnej lub neuroinomalnej
- Poprzednie interwencje neurochirurgiczne w mózgu dowolnego rodzaju.
- niemożność poddania się znieczulenia ogólnego
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Grupa badawcza
Pacjenci uczestniczących w klinice ambulatoryjnej NPH zostali prospektywnie włączeni do badania.
Kryteriami włączenia były: (i) diagnoza kliniczna i radiologiczna prawdopodobnego NPH zgodnie z istniejącymi wytycznymi i (ii) wiekiem ponad 50 lat.
Kryteriami wykluczenia były: (i) niemożność poddania się MR; (ii) diagnoza dowolnej innej patologii neurologicznej, szczególnie neurodegeneracyjnej lub neuroinę; (iii) poprzednie interwencje neurochirurgiczne w mózgu dowolnego rodzaju; (iv) Niezdolność do znieczulenia ogólnego.
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Grupa kontrolna
Zdrowa grupa kontrolna pacjentów (grupa HC) dopasowała się do wieku z grupą IR, przeszła MR w badaniu DTI-ALPS.
Kryteriami wykluczenia dla tej grupy były: (i) poprzednią diagnozę dowolnego zaburzenia neurologicznego dowolnego typu.
(ii) historia interwencji neurochirurgicznej; oraz (iii) wcześniejsza diagnoza nowotworu dowolnego rodzaju.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Porównanie grupy badawczej i kontrolnej
Ramy czasowe: 4 lata
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Różnica we wskaźniku Alp DTI między pacjentami NPH a zdrowymi kontrolami
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4 lata
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Różnica w odpowiedzi na test opukowy między pacjentami z NPH, którzy odpowiedzieli a tymi, którzy nie odpowiedzieli
Ramy czasowe: 4 lata
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Różnica w indeksie ALPS DTI między pacjentami z NPH, którzy zareagowali na test kraniotomii (i przeszli zespolenie komorowo-otrzewnowe) a tymi, którzy nie zareagowali
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4 lata
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Zmiana wskaźnika DTI ALPS w trakcie leczenia u pacjentów z NPH
Ramy czasowe: 4 lata
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Różnica w indeksie DTI ALPS u pacjentów z NPH między T0 (przed TT), T1 (po TT) i T3 (po założeniu zastawki VP)
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4 lata
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Zmiana stężeń biomarkerów zwyrodnieniowych w płynie mózgowo-rdzeniowym
Ramy czasowe: 4 lata
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Zmiany biomarkerów degeneracyjnych w płynie mózgowo-rdzeniowym (białko tau całkowite, białko p-181 tau, białko Aβ42 i białko Aβ40) pomiędzy T1, T2 i T3
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4 lata
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Morgan A Broggi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 czerwca 2021
Zakończenie podstawowe (Rzeczywisty)
31 sierpnia 2024
Ukończenie studiów (Rzeczywisty)
31 grudnia 2024
Daty rejestracji na studia
Pierwszy przesłany
26 lutego 2025
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 lutego 2025
Pierwszy wysłany (Rzeczywisty)
4 marca 2025
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 lutego 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lutego 2026
Ostatnia weryfikacja
1 lutego 2025
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GLINFANPH_2021
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .