NCT01794195

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

February 12, 2013

Last Update Submit

June 30, 2014

Conditions

Keywords

Parkinson's diseaseApathydiffusion tensor imagingtractography

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

EXPERIMENTAL

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

non apathetic paired patients

EXPERIMENTAL

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

healthy paired control

EXPERIMENTAL

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

Interventions

apathetic patients with Parkinson's diseasehealthy paired controlnon apathetic paired patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Parkinson DiseaseLethargy

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Franck DURIF

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

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

Locations