Not yet taking people in FranceNo phase

Brain MRI scans to find early signs of Parkinson and PSP

Tests a high-field 7T brain scan in adults with Parkinson disease or PSP.

Key facts

Who runs it: Assistance Publique Hopitaux De Marseille
Where: Aix-en-Provence, Aubagne, Avignon, Nice, Nîmes, and Toulon, FranceSee the 6 sites
Trial code: NCT06155942
Registry title: Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes
Status: Not yet recruiting
People taking part: 63 people, planned
Started: 15 Jan 2024
Expected to end: 15 Jan 2028
Type of study: Interventional, 3 groups
Treatments tested: 7 Tesla MRI
Record updated: 5 December 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 40 to 80 with early Parkinson's disease or progressive supranuclear palsy (PSP), and for people without brain disease as a comparison group. All have a 7T brain MRI scan.

Age: 40 to 80 years
Sex: All sexes
Disease stage: Parkinson's disease or PSP, meeting the set diagnostic criteria. The first symptom (rigidity, slowness of movement, tremor; for PSP also falls or cognitive problems) began less than 36 months ago. A comparison group has no known brain or nerve disease.

Main reasons for not taking part

Another disease of the central nervous system, such as stroke, repeated head injury or encephalitis
Anything that makes 7T MRI unsafe, such as a pacemaker, cochlear implant, metal in the eye or metallic heart valve
Claustrophobia or another condition that prevents a full MRI
Memory and thinking test (MOCA) score below 25 out of 30 (Parkinson's group)
Pregnant or breast-feeding women, or people under guardianship or deprived of liberty

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

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

Who cannot take part

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
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)

Other criteria

For Parkinson Disease:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 80 years old?

Where in France

Ch Pays D'AixAix-en-Provence, FranceContact: Silvia Di Legge, MDNo longer taking part
Hôpital Privé La Casamance - Service de NeurologieAubagne, FranceContact: Emmanuelle Boutin-GrobNo longer taking part
Centre Hospitalier Avignon - Service de NeurologieAvignon, FranceContact: Stephan Grimaldi, MDNo longer taking part
CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de NeurologieNice, FranceContact: Cosmin Alecu, MDNo longer taking part
CENTRE HOSPITALIER NIMES - Service de NeurologieNîmes, FranceContact: Giovanni Castelnovo, MDNo longer taking part
Centre Hospitalier Sainte Musse ToulonToulon, FranceContact: Elena RusuNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

Patients with Parkinson DiseaseOther group
Treatment: 7 Tesla MRI
Patients with Progressive Supranuclear PalsyOther group
Treatment: 7 Tesla MRI
Healthy volunteersOther group
Treatment: 7 Tesla MRI