Innovative Biomarkers in de Novo Parkinson's Disease

NCT03940677 | Terminated

• 1 other identifier: 2018-A02413-52
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Healthy Controls Group - Age and Sex-matched

Keywords

Biomarkers; Magnetic resonance imaging (MRI); Neuropsychology; Transcranial magnetic stimulation (TMS)

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Parkinson's disease patient

OTHER

Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms

Procedure: Brain MRI; Procedure: TMS-EEG; Behavioral: Behavioral and cognitive battery; Other: Clinical evaluation and clinical scales

Healthy controls

OTHER

Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination

Procedure: Brain MRI; Procedure: TMS-EEG; Behavioral: Behavioral and cognitive battery; Other: Clinical evaluation and clinical scales

Interventions

Brain MRI PROCEDURE

3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI

Healthy controls; Parkinson's disease patient

TMS-EEG PROCEDURE

Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study

Healthy controls; Parkinson's disease patient

Behavioral and cognitive battery BEHAVIORAL

Emotional, attentional and behavioral assessment using predefine scales and measures

Healthy controls; Parkinson's disease patient

Clinical evaluation and clinical scales OTHER

Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS

Healthy controls; Parkinson's disease patient

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital, Clermont-Ferrand: collaborator
• Grenoble Institut des Neurosciences: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elena Moro, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 7, 2019
• Study Start: April 25, 2019
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

FR (1)