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Parkinson DiseaseSODIPARKNCT06155942

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

A study testing 7 Tesla MRI in people with Parkinson Disease and Progressive Supranuclear Palsy, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
What is being tested?
7 Tesla MRI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
6 sitesFrance
Study dates
15 Jan 2024to 15 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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 join

  • 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:
Show all 15Show fewer
  • 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:
  • 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).

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephan Grimaldi, MD contact

0491385266 ext. 33

stephan.grimaldi@ap-hm.fr

6 sites in 1 country

France6 sites

  • Ch Pays D'Aix

    Aix-en-Provence, 13080

    Silvia Di Legge, MD, sdilegge@ch-aix.fr

  • Hôpital Privé La Casamance - Service de Neurologie

    Aubagne, 13400

    Emmanuelle Boutin-Grob, boutinemmanuelle@gmail.com

  • Centre Hospitalier Avignon - Service de Neurologie

    Avignon, 84000

  • CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie

    Nice, 06000

    Cosmin Alecu, MD, alecu.c@chu-nice.fr

  • CENTRE HOSPITALIER NIMES - Service de Neurologie

    Nîmes, 30000

    Giovanni Castelnovo, MD, giovanni.castelnovo@chu-nimes.fr

  • CENTRE HOSPITALIER SAINTE MUSSE - Toulon

    Toulon, 83000

    Elena Rusu, elena-camelia.rusu@ch-toulon.fr

Other trials in France

About this study

Official title: Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes: Analysis in Very High Field (7T) Brain MRI.

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.

Being tested
7 Tesla MRI
Keywords
MRI, Parkinson disease, progressive supranuclear palsy, biomarkers
Medical subject headings
Parkinson Disease, Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7 Tesla MRIProcedure or surgery

    Also called Questionnaires

    Patients will have a 7T MRI and questionnaires

Study groups in NCT06155942
Study groupRoleWhat they receive
Patients with Parkinson DiseaseOtherNot described
Receives: Procedure: 7 Tesla MRI
Patients with Progressive Supranuclear PalsyOtherNot described
Receives: Procedure: 7 Tesla MRI
Healthy volunteersOtherNot described
Receives: Procedure: 7 Tesla MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sodium accumulation between Parkinson disease patients and Progressive Supranuclear Palsy

    Comparison of intracerebral sodium accumulation measured by very high-field (7T) cerebral MRI between subjects with Idiopathic Parkinson's Disease and subjects with early-stage Progressive Supra-Nuclear Palsy

    Measured: Between month 0 and month 3 after inclusion

Secondary outcomes (91)

  1. Sodium accumulation between Parkinson disease patients (MPI) and control subjects

    Comparison of intracerebral sodium accumulation between subjects with early-stage Parkinson's Disease (PD) and control subjects.

    Measured: Between month 0 and month 3 after inclusion

  2. Sodium accumulation between Progressive Supra-nuclear patients (soPSP) and control subjects

    Comparison of intracerebral sodium accumulation between subjects with soPSP and control subjects.

    Measured: Between month 0 and month 3 after inclusion

  3. Brain atrophy between MPI and soPSP patients

    3D mapping of brain atrophy differences measured in Voxel Based Morphometry (VBM), value in cm3

    Measured: Between month 0 and month 3 after inclusion

  4. Brain atrophy between MPI and control group

    3D mapping of brain atrophy differences measured in Voxel Based Morphometry (VBM), value in cm3

    Measured: Between month 0 and month 3 after inclusion

  5. Brain atrophy between soPSP and control group

    3D mapping of brain atrophy differences measured in Voxel Based Morphometry (VBM), value in cm3

    Measured: Between month 0 and month 3 after inclusion

  6. Iron accumulation between soPSP and control group

    3D mapping of iron accumulation differences measured by Quantitative Susceptibility Mapping (QSM), values in ppm

    Measured: Between month 0 and month 3 after inclusion

  7. Iron accumulation between MPI and soPSP patients

    3D mapping of iron accumulation differences measured by Quantitative Susceptibility Mapping (QSM), values in ppm

    Measured: Between month 0 and month 3 after inclusion

  8. Iron accumulation between soPSP patients and control group

    3D mapping of iron accumulation differences measured by Quantitative Susceptibility Mapping (QSM), values in ppm

    Measured: Between month 0 and month 3 after inclusion

  9. Accumulation of neuromelanin between MPI and soPSP patients

    3D mapping of neuromelanin differences (signal/MT ratio)

    Measured: Between month 0 and month 3 after inclusion

  10. Accumulation of neuromelanin between MPI patients and control group

    3D mapping of neuromelanin differences (signal/MT ratio)

    Measured: Between month 0 and month 3 after inclusion

  11. Accumulation of neuromelanin between soPSP patients and control group

    3D mapping of neuromelanin differences (signal/MT ratio)

    Measured: Between month 0 and month 3 after inclusion

  12. Movement of water molecules between MPI and soPSP patients

    3D mapping of differences in mean diffusivity (DM), values in mm2/s

    Measured: Between month 0 and month 3 after inclusion

  13. Movement of water molecules between MPI patients and control group

    3D mapping of differences in mean diffusivity (DM), values in mm2/s

    Measured: Between month 0 and month 3 after inclusion

  14. Movement of water molecules between soPSP patients and control group

    3D mapping of differences in mean diffusivity (DM), values in mm2/s

    Measured: Between month 0 and month 3 after inclusion

  15. Structural connectivity between MPI and soPSP patients

    3D mapping of anisotropy fraction (AF) differences, values between 0 and 1

    Measured: Between month 0 and month 3 after inclusion

  16. Structural connectivity between soPSP patients and control group

    3D mapping of anisotropy fraction (AF) differences, values between 0 and 1

    Measured: Between month 0 and month 3 after inclusion

  17. Structural connectivity between MPI patients and control group

    3D mapping of anisotropy fraction (AF) differences, values between 0 and 1

    Measured: Between month 0 and month 3 after inclusion

  18. Measurement of the dependency between sodium accumulation and age

    Correlation between sodium concentration (mmol/L) and age

    Measured: Between month 0 and month 3 after inclusion

  19. Measurement of the dependency between sodium accumulation and sex

    Correlation between sodium concentration (mmol/L) and sex

    Measured: Between month 0 and month 3 after inclusion

  20. Measurement of the dependency between sodium accumulation and laterality

    Correlation between sodium concentration (mmol/L) and laterality

    Measured: Between month 0 and month 3 after inclusion

  21. Measurement of the dependency between brain atrophy and sex

    Measure by Voxel Based Morphometry (VBM) in cm3 and sex

    Measured: Between month 0 and month 3 after inclusion

  22. Measurement of the dependency between brain atrophy and age

    Measure by Voxel Based Morphometry (VBM) in cm3 and age

    Measured: Between month 0 and month 3 after inclusion

  23. Measurement of the dependency between brain atrophy and laterality

    Measure by Voxel Based Morphometry (VBM) in cm3 and laterality

    Measured: Between month 0 and month 3 after inclusion

  24. Measurement of the dependency between iron accumulation and age

    Measure by Quantitative Susceptibility Mapping (QSM) in ppm and age

    Measured: Between month 0 and month 3 after inclusion

  25. Measurement of the dependency between iron accumulation and sex

    Measure by Quantitative Susceptibility Mapping (QSM) in ppm and sex

    Measured: Between month 0 and month 3 after inclusion

  26. Measurement of the dependency between iron accumulation and laterality

    Measure by Quantitative Susceptibility Mapping (QSM) in ppm and laterality

    Measured: Between month 0 and month 3 after inclusion

  27. Measurement of the dependency between accumulation of neuromelanin and age

    Correlation between ratio of signal/MT and age

    Measured: Between month 0 and month 3 after inclusion

  28. Measurement of the dependency between accumulation of neuromelanin and sex

    Correlation between ratio of signal/MT and sex

    Measured: Between month 0 and month 3 after inclusion

  29. Measurement of the dependency between accumulation of neuromelanin and laterality

    Correlation between ratio of signal/MT and laterality

    Measured: Between month 0 and month 3 after inclusion

  30. Measurement of the dependency between structural connectivity and age

    Correlation between anisotropy fraction (AF) and age

    Measured: Between month 0 and month 3 after inclusion

  31. Measurement of the dependency between structural connectivity and sex

    Correlation between anisotropy fraction (AF) and sex

    Measured: Between month 0 and month 3 after inclusion

  32. Measurement of the dependency between structural connectivity and laterality

    Correlation between anisotropy fraction (AF) and laterality

    Measured: Between month 0 and month 3 after inclusion

  33. Measurement of the dependency between structural connectivity and duration of disease progression

    Correlation between anisotropy fraction (AF) and duration of the disease

    Measured: Between month 0 and month 3 after inclusion

  34. Measurement of the dependency between accumulation of neuromelanin and duration of disease progression

    Correlation between ratio of signal/MT and duration of the disease

    Measured: Between month 0 and month 3 after inclusion

  35. Measurement of the dependency between iron accumulation and duration of disease progression

    Measure by Quantitative Susceptibility Mapping (QSM) in ppm and duration of the disease

    Measured: Between month 0 and month 3 after inclusion

  36. Measurement of the dependency between brain atrophy and duration of disease progression

    Measure by Voxel Based Morphometry (VBM) in cm3 and duration of disease progression

    Measured: Between month 0 and month 3 after inclusion

  37. Measurement of the dependency between sodium accumulation and duration of disease progression

    Correlation between sodium concentration (mmol/L) and duration of disease

    Measured: Between month 0 and month 3 after inclusion

  38. Measurement of the dependency between sodium accumulation and sense of smell

    Correlation between sodium concentration (mmol/L) and sense of smell (questionnaire)

    Measured: Between month 0 and month 3 after inclusion

  39. Measurement of the dependency between brain atrophy and sense of smell

    Measure by Voxel Based Morphometry (VBM) in cm3 and sense of smell (questionnaire)

    Measured: Between month 0 and month 3 after inclusion

  40. Measurement of the dependency between iron accumulation and sense of smell

    Measure by Quantitative Susceptibility Mapping (QSM) in ppm and sense of smell (questionnaire)

    Measured: Between month 0 and month 3 after inclusion

  41. Measurement of the dependency between accumulation of neuromelanin and sense of smell

    Correlation between ratio of signal/MT and sense of smell (questionnaire)

    Measured: Between month 0 and month 3 after inclusion

  42. Measurement of the dependency between structural connectivity and sense of smell

    Correlation between anisotropy fraction (AF) and sense of smell (questionnaire)

    Measured: Between month 0 and month 3 after inclusion

  43. Measurement of the dependency between structural connectivity and severity of disease

    Unified Parkinson's Disease Rating Scale (UPDRS), 0 to 199, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  44. Measurement of the dependency between structural connectivity and quality of life

    Schwab \& England score, 0 to 100%, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  45. Measurement of the dependency between accumulation of neuromelanin and quality of life

    Schwab \& England score, 0 to 100%, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  46. Measurement of the dependency between iron accumulation and quality of life

    Schwab \& England score, 0 to 100%, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  47. Measurement of the dependency between brain atrophy and quality of life

    Schwab \& England score, 0 to 100%, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  48. Measurement of the dependency between sodium accumulation and quality of life

    Correlation between Schwab \& England score (Schwab \& England score, 0 to 100%, 0 means better outcome) and sodium concentration (mmol/L)

    Measured: Between month 0 and month 3 after inclusion

  49. Measurement of the dependency between accumulation of neuromelanin and severity of disease

    Unified Parkinson's Disease Rating Scale (UPDRS), 0 to 199, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  50. Measurement of the dependency between iron accumulation and severity of disease

    Unified Parkinson's Disease Rating Scale (UPDRS), 0 to 199, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  51. Measurement of the dependency between brain atrophy and severity of disease

    Unified Parkinson's Disease Rating Scale (UPDRS), 0 to 199, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  52. Measurement of the dependency between sodium accumulation and Hospital Anxiety and Depression

    HAD Echelle (Hospital Anxiety and Depression), 0 to 3, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  53. Measurement of the dependency between brain atrophy and Hospital Anxiety and Depression

    HAD Echelle (Hospital Anxiety and Depression), 0 to 3, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  54. Measurement of the dependency between iron accumulation and Hospital Anxiety and Depression

    HAD Echelle (Hospital Anxiety and Depression), 0 to 3, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  55. Measurement of the dependency between accumulation of neuromelanin and Hospital Anxiety and Depression

    HAD Echelle (Hospital Anxiety and Depression), 0 to 3, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  56. Measurement of the dependency between structural connectivity and Hospital Anxiety and Depression

    HAD Echelle (Hospital Anxiety and Depression), 0 to 3, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  57. Measurement of the dependency between structural connectivity and Sleep Behavior Disorder

    REM Sleep Behavior Disorder Screening Questionnaire, 0 to 13, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  58. Measurement of the dependency between accumulation of neuromelanin and Sleep Behavior Disorder

    REM Sleep Behavior Disorder Screening Questionnaire, 0 to 13, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  59. Measurement of the dependency between iron accumulation and Sleep Behavior Disorder

    REM Sleep Behavior Disorder Screening Questionnaire, 0 to 13, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  60. Measurement of the dependency between brain atrophy and Sleep Behavior Disorder

    REM Sleep Behavior Disorder Screening Questionnaire, 0 to 13, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  61. Measurement of the dependency between sodium accumulation and Sleep Behavior Disorder

    REM Sleep Behavior Disorder Screening Questionnaire, 0 to 13, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  62. Measurement of the dependency between sodium accumulation and motivation scale

    Starkstein motivation scale, 0 to 42, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  63. Measurement of the dependency between brain atrophy and motivation scale

    Starkstein motivation scale, 0 to 42, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  64. Measurement of the dependency between iron accumulation and motivation scale

    Starkstein motivation scale, 0 to 42, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  65. Measurement of the dependency between accumulation of neuromelanin and motivation scale

    Starkstein motivation scale, 0 to 42, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  66. Measurement of the dependency between structural connectivity and motivation scale

    Starkstein motivation scale, 0 to 42, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  67. Measurement of the dependency between structural connectivity and non-motor fluctuations

    Number of non-motor fluctuations

    Measured: Between month 0 and month 3 after inclusion

  68. Measurement of the dependency between accumulation of neuromelanin and non-motor fluctuations

    Number of non-motor fluctuations

    Measured: Between month 0 and month 3 after inclusion

  69. Measurement of the dependency between iron accumulation and non-motor fluctuations

    Number of non-motor fluctuations

    Measured: Between month 0 and month 3 after inclusion

  70. Measurement of the dependency between brain atrophy and non-motor fluctuations

    Number of non-motor fluctuations

    Measured: Between month 0 and month 3 after inclusion

  71. Measurement of the dependency between sodium accumulation and non-motor fluctuations

    Number of non-motor fluctuations

    Measured: Between month 0 and month 3 after inclusion

  72. Measurement of the dependency between sodium accumulation and cognitives functions

    Score Montreal Cognitive Assessment (MoCA), 0 to 30, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  73. Measurement of the dependency between brain atrophy and cognitives functions

    Score Montreal Cognitive Assessment (MoCA), 0 to 30, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  74. Measurement of the dependency between iron accumulation and cognitives functions

    Score Montreal Cognitive Assessment (MoCA), 0 to 30, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  75. Measurement of the dependency between accumulation of neuromelanin and cognitives functions

    Score Montreal Cognitive Assessment (MoCA), 0 to 30, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  76. Measurement of the dependency between structural connectivity and cognitives functions

    Score Montreal Cognitive Assessment (MoCA), 0 to 30, 0 means worse outcome

    Measured: Between month 0 and month 3 after inclusion

  77. Measurement of the dependency between structural connectivity and quality of life

    Parkinson's Disease Questionnaire (PDQ 39), 0 to 156, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  78. Measurement of the dependency between accumulation of neuromelanin and quality of life

    Parkinson's Disease Questionnaire (PDQ 39), 0 to 156, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  79. Measurement of the dependency between iron accumulation and quality of life

    Parkinson's Disease Questionnaire (PDQ 39), 0 to 156, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  80. Measurement of the dependency between brain atrophy and quality of life

    Parkinson's Disease Questionnaire (PDQ 39), 0 to 156, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  81. Measurement of the dependency between sodium accumulation and quality of life

    Parkinson's Disease Questionnaire (PDQ 39), 0 to 156, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  82. Measurement of the dependency between sodium accumulation and hypotension

    Blood pressure test for orthostatic hypotension

    Measured: Between month 0 and month 3 after inclusion

  83. Measurement of the dependency between brain atrophy and hypotension

    Blood pressure test for orthostatic hypotension

    Measured: Between month 0 and month 3 after inclusion

  84. Measurement of the dependency between iron accumulation and hypotension

    Blood pressure test for orthostatic hypotension

    Measured: Between month 0 and month 3 after inclusion

  85. Measurement of the dependency between accumulation of neuromelanin and hypotension

    Blood pressure test for orthostatic hypotension

    Measured: Between month 0 and month 3 after inclusion

  86. Measurement of the dependency between structural connectivity and hypotension

    Blood pressure test for orthostatic hypotension

    Measured: Between month 0 and month 3 after inclusion

  87. Measurement of the dependency between structural connectivity and hallucinations

    Miami Questionnaire, 0 to 70, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  88. Measurement of the dependency between accumulation of neuromelanin and hallucinations

    Miami Questionnaire, 0 to 70, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  89. Measurement of the dependency between iron accumulation and hallucinations

    Miami Questionnaire, 0 to 70, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  90. Measurement of the dependency between brain atrophy and hallucinations

    Miami Questionnaire, 0 to 70, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

  91. Measurement of the dependency between sodium accumulation and hallucinations

    Miami Questionnaire, 0 to 70, 0 means better outcome

    Measured: Between month 0 and month 3 after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2023
  2. Study start15 Jan 2024 (estimated)
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155942
Sponsor's protocol ID
RCAPHM22_0291
Other IDs
ID-RCB
Acronym
SODIPARK
Status last verified
Nov 2023
First submitted
17 Nov 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 7 Tesla MRI in people with Parkinson Disease and Progressive Supranuclear Palsy, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephan Grimaldi, MD (0491385266 ext. 33, stephan.grimaldi@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sodium accumulation between Parkinson disease patients and Progressive Supranuclear Palsy (time frame: Between month 0 and month 3 after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06155942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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