Innovative Biomarkers in de Novo Parkinson's Disease

Parkinson's Disease Clinical Trial

— INNOBIOPARK  

Official title:

Innovative Biomarkers in de Novo Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03940677
• Other study ID #: 2018-A02413-52
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Brain MRI
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
• TMS-EEG
Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study

Behavioral:
• Behavioral and cognitive battery
Emotional, attentional and behavioral assessment using predefine scales and measures

Other:
• Clinical evaluation and clinical scales
Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Grenoble Institut des Neurosciences, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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