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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)

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ClinicalTrials.gov Identifier: NCT02796040
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Impulse Control Disorders Device: MRI Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
Study Start Date : February 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with ICD (impulse control disorder)
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
Device: MRI
patients without ICD (impulse control disorder)
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
Device: MRI



Primary Outcome Measures :
  1. Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Fractional anisotropy in préfrontal cortex [ Time Frame: 1 day ]
  2. Volume of ventral tegmental area [ Time Frame: 1 day ]
  3. Number of fibers between ventral tegmental area and other structures of the reward system [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796040


Contacts
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Contact: Patrick LACARIN 04 73 75 10 81 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Franck DURIF         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Franck DURIF University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02796040     History of Changes
Other Study ID Numbers: CHU-0266
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Parkinson's disease
Impulse control disorders
Diffusion tensor imaging
MRI
Mesocorticolimbic pathway

Additional relevant MeSH terms:
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Disease
Parkinson Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders