Status:
NOT_YET_RECRUITING
Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Parkinson Disease
Progressive Supranuclear Palsy
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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. Pr...
Eligibility Criteria
Inclusion
- For Parkinson Disease:
- 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.
Exclusion
- 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.
- 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:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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.
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
- For Control group:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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.
- Pregnant or breast-feeding women or protected persons (under guardianship, curatorship, deprived of liberty).
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2028
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06155942
Start Date
January 15 2024
End Date
January 15 2028
Last Update
December 5 2023
Active Locations (6)
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1
Ch Pays D'Aix
Aix-en-Provence, France, 13080
2
Hôpital Privé La Casamance - Service de Neurologie
Aubagne, France, 13400
3
Centre Hospitalier Avignon - Service de Neurologie
Avignon, France, 84000
4
CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie
Nice, France, 06000