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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01780467
• Other study ID #: CHU-0139
• Secondary ID: 2012-002768-28
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 21, 2013
• Last updated: January 29, 2013
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Role of dopamine

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of signal modification		From day 1 (without L Dopa) to day 2 (with L Dopa)	Yes
Secondary	Cluster activation size		from day 1 (without L Dopa) to day 2 (with LDopa)	Yes
Secondary	Brain activity indicators		from day 1 (without L Dopa) to day 2 (with L Dopa)	Yes