Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT01794195
Collaborator
(none)
63
1
3
10
6.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diffusion tensor imaging and fibres tracking
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

Behavioral: Diffusion tensor imaging and fibres tracking

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

Behavioral: Diffusion tensor imaging and fibres tracking

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

Behavioral: Diffusion tensor imaging and fibres tracking

Outcome Measures

Primary Outcome Measures

  1. Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor) [at day 1]

Secondary Outcome Measures

  1. Fibres density (number of fibres / voxel) [at day 1]

  2. Bulk diffusivity index [at day 1]

  3. Apparent diffusion coefficient [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Franck DURIF, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01794195
Other Study ID Numbers:
  • CHU-0145
  • 2012-A01293-40
First Posted:
Feb 18, 2013
Last Update Posted:
Jul 1, 2014
Last Verified:
Jun 1, 2014
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2014