Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.

Parkinson's Disease Clinical Trial

— TCI-IRMdiff  

Official title:

Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02796040
• Other study ID #: CHU-0266
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2016
• Last updated: June 10, 2016
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 10 81
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)

• from 18 to 85 years old

• Impulse control disorder (one item ICD =2 at the scale ECMP : Evaluation Comportementale de la maladie de Parkinson)

Exclusion Criteria:

• Dementia (Mini Mental State < 26 or MATTIS < 130)

• Apathy (LARS (Lille Apathy Rating Scale) > 7)

• Depression (MADRS (Montgomery and Alsberg Depression Scale) =16

• Contra indication to MRI (claustrophobia, deep brain stimulation, pace maker…)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Impulse Control Disorders
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• MRI

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 (data of diffusion tensor imaging, a technique of MRI)		1 day	No
Secondary	Fractional anisotropy in préfrontal cortex		1 day	No
Secondary	Volume of ventral tegmental area		1 day	No
Secondary	Number of fibers between ventral tegmental area and other structures of the reward system		1 day	No