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出境医 / 临床实验 / Innovative Biomarkers in de Novo Parkinson's Disease (INNOBIOPARK)
Innovative Biomarkers in de Novo Parkinson's Disease (INNOBIOPARK)
Study Description
Brief Summary:
This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease Healthy Controls Group - Age and Sex-matched | Procedure: Brain MRI Procedure: TMS-EEG Behavioral: Behavioral and cognitive battery Other: Clinical evaluation and clinical scales | Not Applicable |
Detailed Description:
The investigators will use 4 different approaches in parallel:
- detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
- anatomical and perfusional brain evaluation using functional MRI;
- cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
- 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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Innovative Biomarkers in de Novo Parkinson's Disease |
| Actual Study Start Date : | April 25, 2019 |
| Estimated Primary Completion Date : | April 24, 2024 |
| Estimated Study Completion Date : | April 24, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Parkinson's disease patient
Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
|
Procedure: Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
Procedure: TMS-EEG Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral: Behavioral and cognitive battery Emotional, attentional and behavioral assessment using predefine scales and measures
Other: 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
|
Procedure: Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
Procedure: TMS-EEG Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral: Behavioral and cognitive battery Emotional, attentional and behavioral assessment using predefine scales and measures
Other: Clinical evaluation and clinical scales Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
|
Outcome Measures
Primary Outcome Measures :
- To compare cortical excitability differences between subjects [ Time Frame: In a seven months period after inclusion ]The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls
- To compare brain structural differences between subjects [ Time Frame: In a seven months period after inclusion ]All subjects will have a 3 Tesla brain MRI to collect data concerning anatomy. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: T1 and T2, Fast Gray Matter Acquisition T1 Inversion Recovery (FGATIR)
- To compare brain perfusional differences between subjects [ Time Frame: In a seven months period after inclusion ]All subjects will have a 3 Tesla brain MRI to collect data concerning perfusion. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Pseudo-Continuous Arterial Spin Labeling (PCASL), T2 with gadolinium, FLAIR
- To compare brain connectivity differences between subjects [ Time Frame: In a seven months period after inclusion ]All subjects will have a 3 Tesla brain MRI to collect data concerning functional connectivity at rest. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Echo planar imaging (EPI) for the blood oxygen level-dependent effect
- To compare emotional, attentional and behavior differences between subject [ Time Frame: In a seven months period after inclusion ]Subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
- To compare emotional, attentional and behavior differences between subject with functional MRI [ Time Frame: In a seven months period after inclusion ]During a functional MRI study, subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
Eligibility Criteria
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Parkinson's disease
- 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:
- Treatment for Parkinson's disease (except selegiline and rasagiline)
- Severe visual/retinal pathology revealed during ophthalmological assessment
- Hyper-sensibility to gadolinium
- Renal failure
- Specific MRI contraindication
- Specific TMS contraindication
Contacts and Locations
Contacts
| Contact: Pierre Pelissier, Master | + 33 4 76 76 94 59 | ppelissier@chu-grenoble.fr |
Locations
| France | |
| CHU Grenoble Alpes | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Pierre Pelissier, Master + 33 4 76 76 94 59 ppelissier@chu-grenoble.fr | |
| Sub-Investigator: Valerie Fraix, MD, PhD | |
| Sub-Investigator: Sara Meoni, MD, PhD | |
| Sub-Investigator: Anna Castrioto, MD, PhD | |
| Sub-Investigator: Marie Fournier, MD, PhD | |
Sponsors and Collaborators
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Grenoble Institut des Neurosciences
Investigators
| Principal Investigator: | Elena Moro, MD, PhD | CHU Grenoble Alpes |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 4, 2019 | ||||
| First Posted Date ICMJE | May 7, 2019 | ||||
| Last Update Posted Date | March 17, 2021 | ||||
| Actual Study Start Date ICMJE | April 25, 2019 | ||||
| Estimated Primary Completion Date | April 24, 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Innovative Biomarkers in de Novo Parkinson's Disease | ||||
| Official Title ICMJE | Innovative Biomarkers in de Novo Parkinson's Disease | ||||
| Brief Summary | This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase. | ||||
| Detailed Description |
The investigators will use 4 different approaches in parallel:
The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | April 24, 2024 | ||||
| Estimated Primary Completion Date | April 24, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03940677 | ||||
| Other Study ID Numbers ICMJE | 2018-A02413-52 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Grenoble | ||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University Hospital, Grenoble | ||||
| Verification Date | March 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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