- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794195
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Use lay language.
Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.
Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
3 groups :
- 20 apathetic patients with Parkinson's disease
- 20 non apathetic paired patients)
- 20 healthy paired control
Description of the protocol for patients :
J0 : Inclusion visit (duration : 4h):
- motor assessment (UPDRS)
- neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.
Depression assessment : Montgomery et Alsberg depression rating scale (MADRS)
J0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Patients :
- Men or women aged between 18 -85 years
- Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias
- Non dement (MMS ≥ 26 ; MATTIS ≥ 130)
- Affiliated to National Health system
- Having given their informed consent
Healthy controls
- Men or women aged between 18 -85 years
- Affiliated to National Health system
- Having given their informed consent
Exclusion Criteria:
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Psychiatric pathology
- Severe tremor form of PD
- Depression (MADRS >16)., dementia (MMS < 26, MATTIS < 130).
- Pregnant
- Under guardianship
- In excluding period for another study
- Any contra-indication to MRI
Healthy subject
- Subject with neurological, psychiatric diseases
- Depression, dementia, apathy
- Pregnant
- Under guardianship
- In excluding period for another study
- Any contra-indication to MRI
Study Plan
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: apathetic patients with Parkinson's disease
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
|
|
|
EXPERIMENTAL: non apathetic paired patients
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
|
|
|
EXPERIMENTAL: healthy paired control
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)
Time Frame: at day 1
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fibres density (number of fibres / voxel)
Time Frame: at day 1
|
at day 1
|
|
Bulk diffusivity index
Time Frame: at day 1
|
at day 1
|
|
Apparent diffusion coefficient
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0145
- 2012-A01293-40
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