Innovative Biomarkers in de Novo Parkinson's Disease - Clinical Trial for Parkinson's Disease | NCT03940677

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Brain MRI

TMS-EEG

Behavioral and cognitive battery

Clinical evaluation and clinical scales

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Biomarkers, Magnetic resonance imaging (MRI), Neuropsychology, Transcranial magnetic stimulation (TMS)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU Grenoble Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Parkinson's disease patient

Healthy controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

To compare cortical excitability differences between subjects

The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls

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)

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

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03940677

First Posted

April 4, 2019

Last Updated

May 6, 2022

Sponsor

University Hospital, Grenoble

Collaborators

University Hospital, Clermont-Ferrand, Grenoble Institut des Neurosciences

1. Study Identification

Unique Protocol Identification Number

NCT03940677

Brief Title

Innovative Biomarkers in de Novo Parkinson's Disease

Acronym

INNOBIOPARK

Official Title

Innovative Biomarkers in de Novo Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

end of funding support

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

December 9, 2021 (Actual)

Study Completion Date

December 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

University Hospital, Clermont-Ferrand, Grenoble Institut des Neurosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parkinson's disease patient

Arm Type

Other

Arm Description

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

Arm Title

Healthy controls

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Brain MRI

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TMS-EEG

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Behavioral and cognitive battery

Intervention Description

Emotional, attentional and behavioral assessment using predefine scales and measures

Intervention Type

Other

Intervention Name(s)

Clinical evaluation and clinical scales

Intervention Description

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

Primary Outcome Measure Information:

Title

To compare cortical excitability differences between subjects

Description

The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls

Time Frame