Influence of Emotions on Decision-making in Parkinson's Disease

Influence of Emotions on Decision-making in Parkinson's Disease



Sponsors


Source

Centre Hospitalier Universitaire de Saint Etienne

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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. 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.

Overall Status

Not yet recruiting

Start Date

2017-11-01

Completion Date

2019-11-01

Primary Completion Date

2019-11-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

net score of Iowa Gambling Task Test
day 1

Enrollment

32

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test

Arm Group Label

patients with Parkinson's disease

witnesses



Intervention Type

Other

Intervention Name


Description

viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale

Arm Group Label

patients with Parkinson's disease

witnesses



Intervention Type

Other

Intervention Name


Description

Test of Iowa Gambling Task

Arm Group Label

patients with Parkinson's disease

witnesses




Eligibility

Criteria

Inclusion Criteria for patients :

- Diagnosis of the disease carried out by a hospital doctor

- Stable treatment for two months minimum.

- Mini-Mental Parkinson > 26

- Under dopaminergic treatment

Exclusion Criteria for patients :

- other neurological or psychiatric antecedents

- anxio-depressive symptomatology

- delusional or psychotic state

Inclusion Criteria for witnesses :

- matched in age and sex

- Vision and hearing normal or successfully corrected

- Understand the French language

- general level in the test standard

Exclusion Criteria for witnesses :

- neurological or psychiatric diseases

- anxio-depressive symptomatology

Gender

All

Minimum Age

50 Years

Maximum Age

65 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Céline BORG, MD

Phone

(0)4 77 82 88 82

Phone Ext

33

Email



Location

Facility

Status

Contact

Investigator

CHU de Saint Etienne
Saint-Étienne 42055 France
Not yet recruiting
Last Name: Céline BORG, MD
Phone: (0)4 77 82 88 82
Phone Ext: 33
Email: [email protected]
Last Name: Jean Claude GETENET, MD
Role: Sub-Investigator

Location Countries

Country

France


Verification Date

2017-11-01

Lastchanged Date

2017-11-10

Firstreceived Date

2017-11-10

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

2017-A02690-53

Number Of Arms

2

Arm Group

Arm Group Label

patients with Parkinson's disease

Arm Group Type

Other

Description

cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
viewing of video : scale of differential emotions and Positive and Negative Affect Scale
Test of Iowa Gambling Task


Arm Group Label

witnesses

Arm Group Type

Other

Description

cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
viewing of video : scale of differential emotions and Positive and Negative Affect Scale
Test of Iowa Gambling Task



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Marie PEURIERE

Phone

(0)4 77 82 92 72

Phone Ext

33

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

None (Open Label)


Study First Submitted

November 10, 2017

Study First Submitted Qc

November 10, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 10, 2017

Last Update Submitted Qc

November 10, 2017

Last Update Posted

November 17, 2017


ClinicalTrials.gov processed this data on November 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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