Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients

January 29, 2013 updated by: University Hospital, Clermont-Ferrand

Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • In excluding period for another study
  • Any contra-indication to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with and without treatment by L dopa)
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
Other: healthy paired control
to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Behavioral: Role of dopamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of signal modification
Time Frame: From day 1 (without L Dopa) to day 2 (with L Dopa)
From day 1 (without L Dopa) to day 2 (with L Dopa)

Secondary Outcome Measures

Outcome Measure
Time Frame
Cluster activation size
Time Frame: from day 1 (without L Dopa) to day 2 (with LDopa)
from day 1 (without L Dopa) to day 2 (with LDopa)
Brain activity indicators
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
from day 1 (without L Dopa) to day 2 (with L Dopa)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Ulla MIGUEL, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0139
  • 2012-002768-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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