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NCT Number: NCT06155942

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Progressive Supranuclear Palsy Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Pays D'Aix, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For Parkinson Disease:

Inclusion criteria

  • 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 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 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).

Treatment and study plan

7 Tesla MRI

Procedure

Patients will have a 7T MRI and questionnaires

Other names: Questionnaires

Primary outcomes

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

    Time frame: Between month 0 and month 3 after inclusion

    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

Secondary outcomes

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

  3. Brain atrophy between MPI and soPSP patients

    Time frame: Between month 0 and month 3 after inclusion

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

  4. Brain atrophy between MPI and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  5. Brain atrophy between soPSP and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  6. Iron accumulation between soPSP and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  7. Iron accumulation between MPI and soPSP patients

    Time frame: Between month 0 and month 3 after inclusion

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

  8. Iron accumulation between soPSP patients and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  9. Accumulation of neuromelanin between MPI and soPSP patients

    Time frame: Between month 0 and month 3 after inclusion

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

  10. Accumulation of neuromelanin between MPI patients and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  11. Accumulation of neuromelanin between soPSP patients and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  12. Movement of water molecules between MPI and soPSP patients

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

  15. Structural connectivity between MPI and soPSP patients

    Time frame: Between month 0 and month 3 after inclusion

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

  16. Structural connectivity between soPSP patients and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  17. Structural connectivity between MPI patients and control group

    Time frame: Between month 0 and month 3 after inclusion

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

  18. Measurement of the dependency between sodium accumulation and age

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between sodium concentration (mmol/L) and age

  19. Measurement of the dependency between sodium accumulation and sex

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between sodium concentration (mmol/L) and sex

  20. Measurement of the dependency between sodium accumulation and laterality

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between sodium concentration (mmol/L) and laterality

  21. Measurement of the dependency between brain atrophy and sex

    Time frame: Between month 0 and month 3 after inclusion

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

  22. Measurement of the dependency between brain atrophy and age

    Time frame: Between month 0 and month 3 after inclusion

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

  23. Measurement of the dependency between brain atrophy and laterality

    Time frame: Between month 0 and month 3 after inclusion

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

  24. Measurement of the dependency between iron accumulation and age

    Time frame: Between month 0 and month 3 after inclusion

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

  25. Measurement of the dependency between iron accumulation and sex

    Time frame: Between month 0 and month 3 after inclusion

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

  26. Measurement of the dependency between iron accumulation and laterality

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between ratio of signal/MT and age

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

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between ratio of signal/MT and sex

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

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between ratio of signal/MT and laterality

  30. Measurement of the dependency between structural connectivity and age

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between anisotropy fraction (AF) and age

  31. Measurement of the dependency between structural connectivity and sex

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between anisotropy fraction (AF) and sex

  32. Measurement of the dependency between structural connectivity and laterality

    Time frame: Between month 0 and month 3 after inclusion

    Correlation between anisotropy fraction (AF) and laterality

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

    Number of non-motor fluctuations

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

    Time frame: Between month 0 and month 3 after inclusion

    Number of non-motor fluctuations

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

    Time frame: Between month 0 and month 3 after inclusion

    Number of non-motor fluctuations

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

    Time frame: Between month 0 and month 3 after inclusion

    Number of non-motor fluctuations

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

    Time frame: Between month 0 and month 3 after inclusion

    Number of non-motor fluctuations

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

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

    Time frame: Between month 0 and month 3 after inclusion

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

  82. Measurement of the dependency between sodium accumulation and hypotension

    Time frame: Between month 0 and month 3 after inclusion

    Blood pressure test for orthostatic hypotension

  83. Measurement of the dependency between brain atrophy and hypotension

    Time frame: Between month 0 and month 3 after inclusion

    Blood pressure test for orthostatic hypotension

  84. Measurement of the dependency between iron accumulation and hypotension

    Time frame: Between month 0 and month 3 after inclusion

    Blood pressure test for orthostatic hypotension

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

    Time frame: Between month 0 and month 3 after inclusion

    Blood pressure test for orthostatic hypotension

  86. Measurement of the dependency between structural connectivity and hypotension

    Time frame: Between month 0 and month 3 after inclusion

    Blood pressure test for orthostatic hypotension

  87. Measurement of the dependency between structural connectivity and hallucinations

    Time frame: Between month 0 and month 3 after inclusion

    Miami Questionnaire, 0 to 70, 0 means better outcome

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

    Time frame: Between month 0 and month 3 after inclusion

    Miami Questionnaire, 0 to 70, 0 means better outcome

  89. Measurement of the dependency between iron accumulation and hallucinations

    Time frame: Between month 0 and month 3 after inclusion

    Miami Questionnaire, 0 to 70, 0 means better outcome

  90. Measurement of the dependency between brain atrophy and hallucinations

    Time frame: Between month 0 and month 3 after inclusion

    Miami Questionnaire, 0 to 70, 0 means better outcome

  91. Measurement of the dependency between sodium accumulation and hallucinations

    Time frame: Between month 0 and month 3 after inclusion

    Miami Questionnaire, 0 to 70, 0 means better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Stephan Grimaldi, MD

CONTACT

[email protected]

0491385266 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: SODIPARK

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 5, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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