Glymfaattisen järjestelmän rooli AVALUtoi MR -kuvantamisen NPH: n diagnosoinnissa ja hoidossa (GLINFANPH_2021)
maanantai 9. helmikuuta 2026 päivittänyt: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Tämän havainnollisen tutkimuksen tavoitteena on arvioida DTI-ALP: ien roolia NPH: n diagnostisessa ja terapeuttisessa hoidossa
Tärkeimmät kysymykset, joihin sen tavoitteena on vastata, ovat:
- Onko glymphaattinen järjestelmä (GS) tosiasiallisesti heikentynyt NPH: ssä
- Voiko DTI-ALPS-indeksi ennustaa positiivisen vasteen TAP-testiin (TT) ja Ventrulo-peritoneaaliseen shuntin (VPS) leikkaukseen.
Terveellinen potilaiden kontrolliryhmä (HC-ryhmä), joka vastaa ikäänsä tutkimusryhmän kanssa, tehdään MR DTI-ALPS-tutkimuksella
Tutkimuksen yleiskatsaus
Tila
Valmis
Yksityiskohtainen kuvaus
Ilmoittautuneet potilaat seurasivat diagnostista terapeuttista reittiä, joka koostui seuraavista vaiheista:
- T0: MR DTI-ALPS-tutkimuksella;
- T1 (7 päivän kuluessa T0: sta): Kliininen ja neurokirurginen arviointi NPH-spesifisillä luokitusasteikoilla (yksityiskohtaisesti alla) ennen lannerangan TT: tä ja sen jälkeen, mukaan lukien avautumispaineen mittaukset, CSF: n 40-50 ml: n tyhjennys ja näytteiden kerääminen neurodegeneratiivisille biomarkkereille (β-amyloidi 40, 42 kokonais- ja p-tau) kvantifiointi. MR, jolla on DTI-ALPS-tutkimus 6 tunnin sisällä TT: stä;
- T2 (3 kuukauden kuluessa T1: stä): Potilaille, joilla oli positiivinen TT-vaste (mukaan lukien vastaajat, IR-ryhmä) tehtiin VPS-leikkaus, ja CSF-näytteet kerättiin samoille neurodegeneratiivisille biomarkkereille (β-amyloid 40, 42 yhteensä ja P-Tau);
- T3 (vain kolme kuukautta leikkauksen jälkeen, vain IR-ryhmä): Kliininen ja neurokirurginen arviointi käyttämällä NPH-spesifisiä luokitusasteikkoja luokittelemaan potilaat parantuneiksi, muuttumattomiksi tai pahentuneiksi verrattuna niiden preoperatiiviseen tilaan; MR DTI-ALPS-tutkimuksella.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
29
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Milan, Italia, 20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Potilaat, joihin normaali paine -hydrokephalus vaikuttaa
Kuvaus
Epäillyt NPH -potilaat seuraavien mukaan:
Sisällyttämiskriteerit:
- todennäköisen NPH: n kliininen ja radiologinen diagnoosi olemassa olevien ohjeiden mukaisesti
- yli 50 vuoden ikä
Poissulkemiskriteerit:
- kyvyttömyys käydä läpi
- minkä tahansa muun neurologisen patologian, erityisesti neurodegeneratiivisen tai neuroinflammatorisen diagnoosi
- Aikaisemmat neurokirurgiset interventiot minkä tahansa tyyppisissä aivoissa.
- kyvyttömyys suorittaa yleistä anestesiaa
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Tutkimusryhmä
NPH: n avohoidossa käyvät potilaat osallistuivat prospektiivisesti tutkimukseen.
Sisällyttämiskriteerit olivat: (i) todennäköisen NPH: n kliininen ja radiologinen diagnoosi olemassa olevien ohjeiden ja (ii) ikäisen yli 50 vuoden ikä.
Poissulkemiskriteerit olivat: (i) kyvyttömyys käydä läpi MR; (ii) minkä tahansa muun neurologisen patologian, erityisesti neurodegeneratiivisen tai neuroinflammatorisen diagnoosi; (iii) aikaisemmat neurokirurgiset interventiot minkä tahansa tyyppisissä aivoissa; (iv) kyvyttömyys suorittaa yleistä anestesiaa.
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Kontrolliryhmä
Terveellinen potilasryhmä (HC-ryhmä) vastasi iästä IR-ryhmän kanssa, tehtiin MR DTI-ALPS-tutkimuksella.
Tämän ryhmän poissulkemiskriteerit olivat: (i) minkä tahansa tyyppisen neurologisen häiriön aikaisempi diagnoosi.
(ii) kaikenlaisen neurokirurgisen intervention historia; ja (iii) minkä tahansa tyyppisen pahanlaatuisuuden aikaisempi diagnoosi.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Tutkimus- ja kontrolliryhmän vertailu
Aikaikkuna: 4 vuotta
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Ero DTI ALPS -indeksissä NPH -potilaiden ja terveiden kontrollien välillä
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4 vuotta
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Ero tap-testin vasteessa NPH-potilailla, jotka vastasivat ja jotka eivät vastanneet
Aikaikkuna: 4 vuotta
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Ero DTI ALPS -indeksissä NPH-potilailla, jotka vastasivat tap-testiin (ja joille tehtiin ventrikuloperitoneaalinen shunttileikkaus) ja niillä, jotka eivät vastanneet
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4 vuotta
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DTI ALPS -indeksin muutos NPH-potilaiden hoidon aikana
Aikaikkuna: 4 vuotta
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Ero DTI ALPS -indeksissä NPH-potilailla T0:n (ennen TT:tä), T1:n (TT:n jälkeen) ja T3:n (VP-shuntin jälkeen) välillä
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4 vuotta
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Muutos CSF-degeneratiivisten biomarkkerien pitoisuuksissa
Aikaikkuna: 4 vuotta
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CSF-degeneratiivisten biomarkkereiden (kokonais-tau-proteiini, p-181-tau-proteiini, Aβ42- ja Aβ40-proteiini) vaihtelu T1:n, T2:n ja T3:n välillä
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4 vuotta
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Morgan A Broggi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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