Innovative Biomarkers in de Novo Parkinson's Disease (INNOBIOPARK)

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.

Study Overview

• Status: Terminated
• Conditions: 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

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare cortical excitability differences between subjects	The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls	In a seven months period after inclusion
To compare brain structural differences between subjects	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)	In a seven months period after inclusion
To compare brain perfusional differences between subjects	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	In a seven months period after inclusion
To compare brain connectivity differences between subjects	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	In a seven months period after inclusion
To compare emotional, attentional and behavior differences between subject	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.	In a seven months period after inclusion
To compare emotional, attentional and behavior differences between subject with functional MRI	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.	In a seven months period after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Clermont-Ferrand; Grenoble Institut des Neurosciences
• Investigators: Principal Investigator: Elena Moro, MD, PhD, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Biomarkers; Transcranial magnetic stimulation (TMS); Neuropsychology; Magnetic resonance imaging (MRI)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2018-A02413-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No