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

June 30, 2014 updated by: University Hospital, Clermont-Ferrand

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

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

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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