NCT02796040

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

June 7, 2016

Last Update Submit

June 10, 2016

Conditions

Parkinson's DiseaseImpulse Control Disorders

Keywords

Parkinson's diseaseImpulse control disordersDiffusion tensor imagingMRIMesocorticolimbic pathway

Outcome Measures

Primary Outcomes (1)

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

    1 day

Secondary Outcomes (3)

  • Fractional anisotropy in préfrontal cortex

    1 day

  • Volume of ventral tegmental area

    1 day

  • Number of fibers between ventral tegmental area and other structures of the reward system

    1 day

Study Arms (2)

patients with ICD (impulse control disorder)

EXPERIMENTAL

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)

OTHER

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

Interventions

MRIDEVICE
patients with ICD (impulse control disorder)patients without ICD (impulse control disorder)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDisruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMental Disorders

Study Officials

  • Franck DURIF

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 10 81placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

FR(1)