Parkinson's DiseasePhase 4NCT01780467
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
A Phase 4 study testing Role of dopamine in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Role of dopamine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Psychiatric pathology
- Tremor form (≥ 3 (item tremor of UPDRS))
- Patients with Impulsive control disorders
- Depression, dementia
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Role of dopamine
- Keywords
- Loss aversion, Dopamine, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role of dopamineBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Role of dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of signal modification
Measured: From day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary outcomes (2)
Cluster activation size
Measured: from day 1 (without L Dopa) to day 2 (with LDopa)
Brain activity indicators
Measured: from day 1 (without L Dopa) to day 2 (with L Dopa)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulla MIGUEL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780467
- Sponsor's protocol ID
- CHU-0139
- Other IDs
- 2012-002768-28
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.
- ClinicalTrials.gov ID
- NCT01780467
- Acronym / sponsor ID
- CHU-0139
- Conditions
- Parkinson's Disease
- Keywords
- Loss aversion, Dopamine, Parkinson's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with and without treatment by L dopa) | Experimental | Behavioral: Role of dopamineto 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. |
| healthy paired control | Other | Behavioral: Role of dopamineto highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (17 listed)
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Psychiatric pathology
- Tremor form (≥ 3 (item tremor of UPDRS))
- Patients with Impulsive control disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Role of dopamine | Behavioural | healthy paired control, patients with and without treatment by L dopa) |
Primary outcome
percentage of signal modification
Time frame: From day 1 (without L Dopa) to day 2 (with L Dopa)
2 secondary outcomes
Cluster activation size
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla MIGUEL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Role of dopamine in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of signal modification (time frame: From day 1 (without L Dopa) to day 2 (with L Dopa)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.