Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
43 participants
INTERVENTIONAL
2019-04-25
2021-12-09
Brief Summary
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Detailed Description
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1. detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
2. anatomical and perfusional brain evaluation using functional MRI;
3. cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
4. emotional responses study using a novel paradigm. These 4 modalities will be assessed at baseline, 1 year and 2 years follow-up.
The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Parkinson's disease patient
Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
TMS-EEG
Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral and cognitive battery
Emotional, attentional and behavioral assessment using predefine scales and measures
Clinical evaluation and clinical scales
Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
Healthy controls
Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination
Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
TMS-EEG
Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral and cognitive battery
Emotional, attentional and behavioral assessment using predefine scales and measures
Clinical evaluation and clinical scales
Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
Interventions
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Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
TMS-EEG
Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral and cognitive battery
Emotional, attentional and behavioral assessment using predefine scales and measures
Clinical evaluation and clinical scales
Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
Eligibility Criteria
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Inclusion Criteria
* Asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ;
* Hoehn \& Yahr ≤ 2/5 ;
* Montreal cognitive assessment ≥ 26/30 ;
Exclusion Criteria
* Severe visual/retinal pathology revealed during ophthalmological assessment
* Hyper-sensibility to gadolinium
* Renal failure
* Specific MRI contraindication
* Specific TMS contraindication
30 Years
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Grenoble Institut des Neurosciences
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Elena Moro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble Alpes
Locations
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CHU Grenoble Alpes
Grenoble, , France
Countries
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Other Identifiers
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2018-A02413-52
Identifier Type: -
Identifier Source: org_study_id
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