Clinical trial NCT03940677: Innovative Biomarkers in de Novo Parkinson's Disease
Official title: Innovative Biomarkers in de Novo Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Healthy Controls Group - Age and Sex-matched
Keywords: Biomarkers
Magnetic resonance imaging (MRI)
Neuropsychology
Transcranial magnetic stimulation (TMS)
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
name: Grenoble Institut des Neurosciences
First posted: 2019-05-07
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare cortical excitability differences between subjects
timeFrame: In a seven months period after inclusion
measure: To compare brain structural differences between subjects
timeFrame: In a seven months period after inclusion
measure: To compare brain perfusional differences between subjects
timeFrame: In a seven months period after inclusion
measure: To compare brain connectivity differences between subjects
timeFrame: In a seven months period after inclusion
measure: To compare emotional, attentional and behavior differences between subject
timeFrame: In a seven months period after inclusion
measure: To compare emotional, attentional and behavior differences between subject with functional MRI
timeFrame: In a seven months period after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Elena Moro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: