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

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ClinicalTrials.gov Identifier: NCT01780467
Recruitment Status : Unknown
Verified January 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Role of dopamine Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. percentage of signal modification [ Time Frame: From day 1 (without L Dopa) to day 2 (with L Dopa) ]

Secondary Outcome Measures :
  1. Cluster activation size [ Time Frame: from day 1 (without L Dopa) to day 2 (with LDopa) ]
  2. Brain activity indicators [ Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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): NCT01780467


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Ulla MIGUEL University Hospital, Clermont-Ferrand
More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01780467     History of Changes
Other Study ID Numbers: CHU-0139
2012-002768-28
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Loss aversion
Dopamine
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents