Role of Dopamine on Loss Aversion Behaviour: Study on Par... | NCT01780467

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

NCT01780467

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jan 31, 2013Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

Role of dopamine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-002768-28

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jan 21, 2013

First Submission Date that Met QC Criteria

Jan 29, 2013

First Posted Date

Jan 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2013

Last Update Posted Date

Jan 31, 2013Estimated

Description Module

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.

Detailed Description

Use lay language.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Role of dopamine	Behavioral		healthy paired control patients with and without treatment by L dopa)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Ulla MIGUEL	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided