Parkinson DiseaseNCT03342339
Influence of Emotions on Decision-making in Parkinson's Disease
A study testing cognitive examination, viewing of video and Iowa Gambling Task in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- cognitive examination, viewing of video and Iowa Gambling Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2018to 20 Feb 2020
- Phase
- Interventional
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of the disease carried out by a hospital doctor
- Stable treatment for two months minimum.
- Mini-Mental Parkinson > 26
- Under dopaminergic treatment
- matched in age and sex
- Vision and hearing normal or successfully corrected
- Understand the French language
- general level in the test standard
Who cannot join
- other neurological or psychiatric antecedents
- anxio-depressive symptomatology
- delusional or psychotic state
- neurological or psychiatric diseases
- anxio-depressive symptomatology
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble Alpes
Grenoble
CHU de Saint Etienne
Saint-Etienne, 42055
About this study
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements.
It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.
Read the detailed description
Some research shows that positive emotional states are associated with greater self-confidence, greater optimism, and better regulation of our decision-making. The goal is to test whether positive emotional induction could improve decision-making in Parkinson's disease.
Listening to music would decrease anxiety levels and increase self-esteem levels. Who says Parkinson says dopamine deficiency and so the investigators can think that the investigators can help patients by inducing a positive emotion through musical stimulation.
All participants will be subject to emotional induction. They will be divided into two different conditions: either they will be induced in a positive state, or they will be maintained in a neutral state. For this, video clips (positive or neutral) containing music will be presented. Immediately after the presentation of the video, participants will have to perform the Iowa Gambling Task test. This is a sequential task to evaluate decision-making capabilities.
- Conditions
- Parkinson Disease
- Being tested
- cognitive examination, viewing of video, Iowa Gambling Task
- Keywords
- influence of emotions, positif emotional induction, decision making, Iowa Gambling Task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive examinationOther
mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
viewing of videoOther
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
Iowa Gambling TaskOther
Test of Iowa Gambling Task
| Study group | Role | What they receive |
|---|---|---|
| patients with Parkinson's disease | Other | 1. cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
2. viewing of video : scale of differential emotions and Positive and Negative Affect Scale
3. Test of Iowa Gambling Task Receives: Other: cognitive examination; Other: viewing of video; Other: Iowa Gambling Task |
| witnesses | Other | 1. cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
2. viewing of video : scale of differential emotions and Positive and Negative Affect Scale
3. Test of Iowa Gambling Task Receives: Other: cognitive examination; Other: viewing of video; Other: Iowa Gambling Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
net score of Iowa Gambling Task Test
calculated by adding the number of cards taken in the right pile and subtracting it from the number of cards chosen in the wrong pile
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start8 Feb 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342339
- Sponsor's protocol ID
- 1708168
- Other IDs
- 2017-A02690-53
- Status last verified
- Jan 2021
- First submitted
- 10 Nov 2017
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Emotions on Decision-making in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03342339
- Acronym / sponsor ID
- 1708168
- Conditions
- Parkinson Disease
- Keywords
- influence of emotions, positif emotional induction, decision making, Iowa Gambling Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- 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.
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements.
It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.
Detailed description
Some research shows that positive emotional states are associated with greater self-confidence, greater optimism, and better regulation of our decision-making. The goal is to test whether positive emotional induction could improve decision-making in Parkinson's disease.
Listening to music would decrease anxiety levels and increase self-esteem levels. Who says Parkinson says dopamine deficiency and so the investigators can think that the investigators can help patients by inducing a positive emotion through musical stimulation.
All participants will be subject to emotional induction. They will be divided into two different conditions: either they will be induced in a positive state, or they will be maintained in a neutral state. For this, video clips (positive or neutral) containing music will be presented. Immediately after the presentation of the video, participants will have to perform the Iowa Gambling Task test. This is a sequential task to evaluate decision-making capabilities.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with Parkinson's disease | Other | Other: cognitive examination, Other: viewing of video, Other: Iowa Gambling Task1. cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test 2. viewing of video : scale of differential emotions and Positive and Negative Affect Scale 3. Test of Iowa Gambling Task |
| witnesses | Other | Other: cognitive examination, Other: viewing of video, Other: Iowa Gambling Task1. cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test 2. viewing of video : scale of differential emotions and Positive and Negative Affect Scale 3. Test of Iowa Gambling Task |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of the disease carried out by a hospital doctor
- Stable treatment for two months minimum.
- Mini-Mental Parkinson > 26
- Under dopaminergic treatment
- matched in age and sex
Key exclusion criteria (5 listed)
- other neurological or psychiatric antecedents
- anxio-depressive symptomatology
- delusional or psychotic state
- neurological or psychiatric diseases
- anxio-depressive symptomatology
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 |
|---|---|---|
| cognitive examinationmini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test | Other | patients with Parkinson's disease, witnesses |
| viewing of videoviewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale | Other | patients with Parkinson's disease, witnesses |
| Iowa Gambling TaskTest of Iowa Gambling Task | Other | patients with Parkinson's disease, witnesses |
Primary outcome
net score of Iowa Gambling Task Test
Time frame: day 1
calculated by adding the number of cards taken in the right pile and subtracting it from the number of cards chosen in the wrong pile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive examination, viewing of video and Iowa Gambling Task in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
net score of Iowa Gambling Task Test (time frame: day 1). 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 19 Jan 2021.