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

Primary Purpose

Parkinson's Disease, Impulse Control Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, Impulse control disorders, Diffusion tensor imaging, MRI, Mesocorticolimbic pathway

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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…)

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patients with ICD (impulse control disorder)

patients without ICD (impulse control disorder)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI)

Secondary Outcome Measures

Fractional anisotropy in préfrontal cortex
Volume of ventral tegmental area
Number of fibers between ventral tegmental area and other structures of the reward system

Full Information

First Posted
June 7, 2016
Last Updated
June 10, 2016
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02796040
Brief Title
Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
Acronym
TCI-IRMdiff
Official Title
Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Impulse Control Disorders
Keywords
Parkinson's disease, Impulse control disorders, Diffusion tensor imaging, MRI, Mesocorticolimbic pathway

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with ICD (impulse control disorder)
Arm Type
Experimental
Arm Description
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
Arm Title
patients without ICD (impulse control disorder)
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Fractional anisotropy in préfrontal cortex
Time Frame
1 day
Title
Volume of ventral tegmental area
Time Frame
1 day
Title
Number of fibers between ventral tegmental area and other structures of the reward system
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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…)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 10 81
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck DURIF
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Franck DURIF

12. IPD Sharing Statement

Learn more about this trial

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

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