NCT01780467

Brief Summary

Use lay language. Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money. We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control. 2 groups :

  • 20 parkinsonian patients (tested two times : with and without treatment by L dopa)
  • 20 healthy paired control Description of the protocol for patients : J0 : Inclusion visit (duration : 4h):
  • motor assessment (UPDRS)
  • neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin scale, UPPS, MADRS, Hamilton, LARS). J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or without treatment) : Each acquisition was composed by an orientation sequence+ an anatomic sequence + a functional sequence. For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the MRI acquisitions.

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
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

January 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

January 21, 2013

Last Update Submit

January 29, 2013

Conditions

Parkinson's Disease

Keywords

Loss aversionDopamineParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • percentage of signal modification

    From day 1 (without L Dopa) to day 2 (with L Dopa)

Secondary Outcomes (2)

  • Cluster activation size

    from day 1 (without L Dopa) to day 2 (with LDopa)

  • Brain activity indicators

    from day 1 (without L Dopa) to day 2 (with L Dopa)

Study Arms (2)

patients with and without treatment by L dopa)

EXPERIMENTAL

to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money.

Behavioral: Role of dopamine

healthy paired control

OTHER

to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.

Behavioral: Role of dopamine

Interventions

Role of dopamineBEHAVIORAL
healthy paired controlpatients with and without treatment by L dopa)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients :
  • Men or women aged between 35 -75 years
  • Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias with a disease evolution duration : 5-10 years)
  • With fluctuations in end of doses + morning akinesia.
  • Non dement (MMS\>24 ; Mattis \> 130)
  • Affiliated to National Health system
  • Having given their informed consent
  • Healthy controls
  • Men or women aged between 35 to 75 years
  • Non dement (MMS\>24 )
  • Affiliated to National Health system
  • Having given their informed consent

You may not qualify if:

  • Patients :
  • Patients suffering of an atypical Parkinson syndrome
  • Psychiatric pathology
  • Tremor form (≥ 3 (item tremor of UPDRS))
  • Patients with Impulsive control disorders
  • Depression, dementia
  • Pregnant
  • Under guardianship
  • In excluding period for another study
  • Any contra-indication to MRI
  • Healthy subject
  • Subject with neurological, psychiatric diseases
  • Depression, dementia
  • Pregnant
  • Under guardianship
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ulla MIGUEL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 31, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

FR(1)