NCT06155942Not yet recruiting
Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes
Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes: Analysis in Very High Field (7T) Brain MRI.
Source: ClinicalTrials.gov · Last updated 5 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 17 Nov 2023
- Start date
- 15 Jan 2024
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Parkinson disease
- NCT number
- NCT06155942
What you commit to
- Study type: Interventional
- Planned participants: 63
- From 15 Jan 2024 to the primary completion date, 15 Jan 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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).
Who the study is looking for
- 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
Criteria the registry did not label
- For Parkinson Disease:
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ch Pays D'Aix Coordinator of this site? Confirm its status | Aix-en-Provence | France | Unknown status |
| Hôpital Privé La Casamance - Service de Neurologie Coordinator of this site? Confirm its status | Aubagne | France | Unknown status |
| Centre Hospitalier Avignon - Service de Neurologie Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CENTRE HOSPITALIER NIMES - Service de Neurologie Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Centre Hospitalier Sainte Musse Toulon Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.