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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794195
• Other study ID #: CHU-0145
• Secondary ID: 2012-A01293-40
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: June 30, 2014
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Apathy
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Diffusion tensor imaging and fibres tracking

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)		at day 1	Yes
Secondary	Fibres density (number of fibres / voxel)		at day 1	Yes
Secondary	Bulk diffusivity index		at day 1	Yes
Secondary	Apparent diffusion coefficient		at day 1	Yes