Innovative Biomarkers in de Novo Parkinson's Disease

Not Applicable

Terminated

• Conditions: Parkinson's Disease; Healthy Controls Group - Age and Sex-matched
• Interventions: Procedure: Brain MRI; Procedure: TMS-EEG; Behavioral: Behavioral and cognitive battery; Other: Clinical evaluation and clinical scales

• Registration Number: NCT03940677
• Lead Sponsor: University Hospital, Grenoble

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:

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 Timeline

• Study First Submitted: 2019-04-04
• Study Start: 2019-04-25
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Brain MRI	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination
Parkinson's disease patient	Brain MRI	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
Parkinson's disease patient	Clinical evaluation and clinical scales	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
Parkinson's disease patient	TMS-EEG	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
Parkinson's disease patient	Behavioral and cognitive battery	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms
Healthy controls	TMS-EEG	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination
Healthy controls	Behavioral and cognitive battery	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination
Healthy controls	Clinical evaluation and clinical scales	Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination

Primary Outcome Measures

Name	Time	Method
To compare brain structural differences between subjects	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	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 emotional, attentional and behavior differences between subject	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 cortical excitability differences between subjects	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 connectivity differences between subjects	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 with functional MRI	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.

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France