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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2016 |
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Main ID: |
NCT02796040 |
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Date of registration:
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07/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography. |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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75 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02796040 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Franck DURIF |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 10 81 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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…)
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Impulse Control Disorders
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Parkinson's Disease
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Intervention(s)
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Device: MRI
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Primary Outcome(s)
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Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI)
[Time Frame: 1 day]
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Secondary Outcome(s)
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Volume of ventral tegmental area
[Time Frame: 1 day]
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Number of fibers between ventral tegmental area and other structures of the reward system
[Time Frame: 1 day]
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Fractional anisotropy in préfrontal cortex
[Time Frame: 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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