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NCT Number: 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

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Key information

Conditions

Parkinson's Disease Apathy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Lethargy Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion tensor imaging and fibres tracking

Behavioral

Primary outcomes

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

    Time frame: at day 1

Secondary outcomes

  1. Fibres density (number of fibres / voxel)

    Time frame: at day 1

  2. Bulk diffusivity index

    Time frame: at day 1

  3. Apparent diffusion coefficient

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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