Skip to content

Innovative Biomarkers in de Novo Parkinson's Disease

Innovative Biomarkers in de Novo Parkinson's Disease

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940677
Acronym
INNOBIOPARK
Enrollment
43
Registered
2019-05-07
Start date
2019-04-25
Completion date
2021-12-09
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDUREBrain MRI

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

PROCEDURETMS-EEG

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

BEHAVIORALBehavioral and cognitive battery

Emotional, attentional and behavioral assessment using predefine scales and measures

OTHERClinical evaluation and clinical scales

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

Sponsors

University Hospital, Clermont-Ferrand
CollaboratorOTHER
Grenoble Institut des Neurosciences
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To compare brain perfusional differences between subjectsIn a seven months period after inclusionAll 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 cortical excitability differences between subjectsIn a seven months period after inclusionThe EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls
To compare brain structural differences between subjectsIn a seven months period after inclusionAll 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 connectivity differences between subjectsIn a seven months period after inclusionAll 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 subjectIn a seven months period after inclusionSubjects 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 MRIIn a seven months period after inclusionDuring 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026