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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03940677

2018-A02413-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Parkinson's disease patient

Other group

Description:

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

Treatment:

Procedure: TMS-EEG

Behavioral: Behavioral and cognitive battery

Other: Clinical evaluation and clinical scales

Procedure: Brain MRI

Healthy controls

Other group

Description:

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

Treatment:

Procedure: TMS-EEG

Behavioral: Behavioral and cognitive battery

Other: Clinical evaluation and clinical scales

Procedure: Brain MRI