Clinical Trial: Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
Brief Summary:
Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological substrates of these symptoms are largely unknown.
The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging (DTI).
More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between VTA and the other structures of reward system between this two groups. Other objective is to measure and compare these same variables between Parkinson's patients and healthy controls.
We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's patients to ICD.
Detailed Summary:
Type of study: Prospective, case control study.
Number of centers: 1 (Clermont-Ferrand)
Patients :
Inclusion of 25 patients with Parkinson's disease and impulse control disorders (inclusion's criteria detailed later), 25 matched Parkinson's disease patients without impulse control disorders and 25 healthy volunteers.
Study Performance :
J0 (inclusion; 3 hours) :
Each subject will perform a clinical and neurological examination (UPDRS) and a neuropsychological evaluation for diagnostic and quantification of impulse control disorders and to ensure of the absence of exclusion criteria.
J0+1week (MRI; 1hour) Each subject will then have an MRI acquisition including anatomical sequences (T1 and T2 weighted sequences) and a diffusion tensor imaging sequence (60 directions).
Analysis Analysis (Pre-processing and processing) will be realized with the Oxford Centre for Functional MRI of the Brain (FMRIB) Software (FSL).
Sponsor: University Hospital, Clermont-Ferrand
Current Primary Outcome: Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI) [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Fractional anisotropy in préfrontal cortex [ Time Frame: 1 day ]
- Volume of ventral tegmental area [ Time Frame: 1 day ]
- Number of fibers between ventral tegmental area and other structures of the reward system [ Time Frame: 1 day ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Clermont-Ferrand
Dates:
Date Received: June 7, 2016
Date Started: February 2016
Date Completion: August 2017
Last Updated: June 10, 2016
Last Verified: June 2016
