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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Innovative Biomarkers in de Novo Parkinson's Disease

Clinicaltrials.gov identifier NCT03940677

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

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:Parkinson's Disease
    Healthy Controls Group - Age and Sex-matched
  • Intervention/Treatment: Procedure: Brain MRI
    Procedure: TMS-EEG
    Behavioral: Behavioral and cognitive battery
    Other: Clinical evaluation and clinical scales
  • Phase: N/A
Detailed Description

The investigators will use 4 different approaches in parallel: 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.

Study Design
  • Study Type: Interventional
  • 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: March 2019
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: June 2024
Arms and interventions
Arm Intervention/treatment
Other: 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
Other: 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
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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)
  • 3. 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
  • 4. 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
  • 5. 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.
  • 6. 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
Grenoble

Sponsors and Collaborators

University Hospital, Grenoble

University Hospital, Clermont-Ferrand

Grenoble Institut des Neurosciences

Investigators

Principal Investigator: Elena Moro, MD, PhD CHU Grenoble Alpes

More Information
  • Responsible Party: University Hospital, Grenoble
  • ClinicalTrials.gov Identifier: NCT03940677 History of Changes
  • Other Study ID Numbers: 2018-A02413-52
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Grenoble: Magnetic resonance imaging (MRI)
    Neuropsychology
    Transcranial magnetic stimulation (TMS)
    Biomarkers
  • Additional relevant MeSH terms: Parkinson Disease