Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
2 other identifiers
interventional
63
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 1, 2014
June 1, 2014
10 months
February 12, 2013
June 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)
at day 1
Secondary Outcomes (3)
Fibres density (number of fibres / voxel)
at day 1
Bulk diffusivity index
at day 1
Apparent diffusion coefficient
at day 1
Study Arms (3)
apathetic patients with Parkinson's disease
EXPERIMENTALThe 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
non apathetic paired patients
EXPERIMENTALThe 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
healthy paired control
EXPERIMENTALThe 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck DURIF
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 18, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 1, 2014
Record last verified: 2014-06