NCT06155942Toborzás még nem indult
Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes
Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes: Analysis in Very High Field (7T) Brain MRI.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. dec. 5. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Parkinson's disease (PD) is the most common degenerative Parkinson's syndrome and is linked, among other things, to the excessive accumulation of an abnormally aggregating protein, alpha-synuclein. Progressive Supranuclear Palsy (PSP) is another Parkinson's syndrome, linked, among other things, to the abnormal accumulation of the protein Tau, and expressed clinically by falls, early cognitive impairment and oculomotor disorders, not present in PD. The onset of these disorders is so gradual that differential diagnosis between the two diseases is only possible at a late stage, on average 3 to 5 years after the onset of symptoms. To date, there is a lack of validated imaging biomarkers for diagnosing and monitoring PD and PSP. There is therefore an urgent need for the development of robust biomarkers capable of detecting neurodegeneration at an early stage, in order to aid differential diagnosis as soon as symptoms appear, and to potentially enable these patients to be included in specific therapeutic trials (as these diseases are pathophysiologically different) with potential neuroprotective effects. The development of cutting-edge technologies such as 7T MRI, combined with optimized image processing methods, now enable non-invasive in vivo exploration and analysis of these small structures in terms of ion homeostasis (sodium), microstructure (volumetry, amount of iron and neuromelanin) and connectivity.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 63 (tervezett)
- Első benyújtás
- 2023. nov. 17.
- Kezdés
- 2024. jan. 15.
- Elsődleges befejezés
- 2026. jan. 15.
- Fő szponzor
- Assistance Publique Hopitaux De Marseille
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT06155942
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 63
- 2024. jan. 15. és az elsődleges befejezés (2026. jan. 15.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Patient with a neurological disease of the central nervous system other than those studied (including history of stroke, repeated head trauma, documented encephalitis). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
- Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
- Claustrophobia or any other condition preventing full MRI.
- Patient with a neurological disease of the central nervous system other than those studied (including history of stroke, repeated head trauma, documented encephalitis). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
- Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
- Claustrophobia or any other condition preventing MRI.
- Subjects with a known history of neurological disease of the central nervous system (e.g. Parkinson's disease, Alzheimer's, stroke, brain tumor, multiple sclerosis, amyotrophic lateral sclerosis, repeated head trauma, documented encephalitis, etc.). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
- Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
- Claustrophobia or any other condition preventing MRI.
Egyéb
- Montreal Cognitive Assessment (MOCA) test < 25/30
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
- For Progressive Supra-nuclear Palsy:
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
- For Control group:
- Pregnant or breast-feeding women or protected persons (under guardianship, curatorship, deprived of liberty).
Kiket keres a vizsgálat
- Patients aged between 40 and 80
- Fulfilling the diagnostic criteria for MPI (Postuma et al., 2015)
- First motor symptom (rigidity, akinesia, tremor) less than 36 months ago
- Patient entitled to or affiliated with a social security scheme
- Patients who understood, completed and signed the consent form for study participation.
- Patients aged 40 to 80
- Fulfilling the diagnostic criteria for soPSP (Höglinger et al., 2017) :
- First motor symptom (rigidity, akinesia, tremor) or falls or cognitive impairment (frontal syndrome or language disorder or cortico-basal syndrome) occurring less than 36 months ago
- Patients benefiting from or affiliated to a social security scheme
- Patients who have understood, completed and signed the study participation consent form
- Subjects aged between 40 and 80
- Subjects benefiting from or affiliated with a social security plan
- Subjects who have understood, completed and signed the study participation consent form
A regiszterben nem jelölt feltételek
- For Parkinson Disease:
Életkor a regiszterben: 40 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Ch Pays D'Aix | Aix-en-Provence | Franciaország | Ismeretlen állapot |
| Hôpital Privé La Casamance - Service de Neurologie | Aubagne | Franciaország | Ismeretlen állapot |
| Centre Hospitalier Avignon - Service de Neurologie | Avignon | Franciaország | Ismeretlen állapot |
| CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie | Nice | Franciaország | Ismeretlen állapot |
| CENTRE HOSPITALIER NIMES - Service de Neurologie | Nîmes | Franciaország | Ismeretlen állapot |
| Centre Hospitalier Sainte Musse Toulon | Toulon | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.