Parkinson DiseaseFLUENCENCT01888276
Words Generation in Compulsives Gamblers and Parkinson's Disease Patients
A study testing evaluation of word generation and of motivation in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- evaluation of word generation and of motivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Apr 2014
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy volunteers :
- Subject from 30 to 75 years old (Male and female)
- Subject with French mother tongue
- Subject who give their informed and signed consent.
- Subject affiliated to a social protection program
- For compulsive gamblers :
Show all 11Show fewer
- Subject from 30 to 75 years old (Male and female)
- Subject with French mother tongue
- Subject with at least 5 criteria of 10 DSM IV diagnostic criteria for pathological gambling
- Subject who give their informed and signed consent.
- Subject affiliated to a social protection program
Who cannot join
- For healthy volunteers and compulsive gamblers :
- Presence of apathy defined as a score greater or equal to 14 on the scale of Starkstein
- Presence of severe depression defined as a score greater or equal to 25 on the scale BDI (Beck Depression Inventory)
- Presence of dementia defined as a score below 25 on the MMSE
- Subject with vision problems making it impossible for the tests
- Pregnant women
- Subject under tutelage, curatelle or law protection
- Subject included in an other clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system.
Thanks to the words generation test, which reflects the cortico-subcortical loop functioning, involved in motivation, we want to evaluate and compare using tools (words generation and behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic disorders which were explored in another study.
Read the detailed description
The main objective of this study is to evaluate performance during words generation in gamblers and healthy volunteers compare to those of PD patients with and without hyper-dopaminergic behaviors collected during another study.
2 groups of subjects will be recruited for the study: 20 compulsive gamblers and 20 healthy volunteers
Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The test of Stroop that assesses selective attention
During the session 2:
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The task of the casino (Iowa Gambling Test)
- The task of landing
- The test of Stroop
We supposed that the performance of compulsive gamblers in words generation test will be higher than those of healthy volunteers, themselves superior to those of PD patients with a hyper-dopaminergic behavior, themselves superior to those of PD patient without hyper-dopaminergic behavior.
- Conditions
- Parkinson Disease
- Being tested
- evaluation of word generation and of motivation
- Keywords
- Words generation, compulsive gamblers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of word generation and of motivationOther
Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The test of Stroop that assesses selective attention
During the session 2:
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The task of the casino (Iowa Gambling Test)
- The task of landing
- The test of Stroop
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | evaluation of word generation and of motivation Receives: Other: evaluation of word generation and of motivation |
| compulsive gamblers | Other | evaluation of word generation and of motivation Receives: Other: evaluation of word generation and of motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changement of number of mistake during the words generation test
Measured: one hour
Secondary outcomes (1)
changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionApr 2014
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 University Hospital, ToulouseThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Brefel, MD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888276
- Sponsor's protocol ID
- 11 225 02
- Acronym
- FLUENCE
- Status last verified
- Jun 2015
- First submitted
- 20 Feb 2012
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT01888276
- Acronym / sponsor ID
- FLUENCE / 11 225 02
- Conditions
- Parkinson Disease
- Keywords
- Words generation, compulsive gamblers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jun 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.
The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system.
Thanks to the words generation test, which reflects the cortico-subcortical loop functioning, involved in motivation, we want to evaluate and compare using tools (words generation and behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic disorders which were explored in another study.
Detailed description
The main objective of this study is to evaluate performance during words generation in gamblers and healthy volunteers compare to those of PD patients with and without hyper-dopaminergic behaviors collected during another study.
2 groups of subjects will be recruited for the study: 20 compulsive gamblers and 20 healthy volunteers
Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The test of Stroop that assesses selective attention
During the session 2:
- The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
- The task of the casino (Iowa Gambling Test)
- The task of landing
- The test of Stroop
We supposed that the performance of compulsive gamblers in words generation test will be higher than those of healthy volunteers, themselves superior to those of PD patients with a hyper-dopaminergic behavior, themselves superior to those of PD patient without hyper-dopaminergic behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Other: evaluation of word generation and of motivationevaluation of word generation and of motivation |
| compulsive gamblers | Other | Other: evaluation of word generation and of motivationevaluation of word generation and of motivation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject from 30 to 75 years old (Male and female)
- Subject with French mother tongue
- Subject who give their informed and signed consent.
- Subject affiliated to a social protection program
- Subject from 30 to 75 years old (Male and female)
Key exclusion criteria (8 listed)
- Presence of apathy defined as a score greater or equal to 14 on the scale of Starkstein
- Presence of severe depression defined as a score greater or equal to 25 on the scale BDI (Beck Depression Inventory)
- Presence of dementia defined as a score below 25 on the MMSE
- Subject with vision problems making it impossible for the tests
- Pregnant women
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 |
|---|---|---|
| evaluation of word generation and of motivationEach subject will realize twice each test during 2 sessions with one hour in between : During the session 1 : * The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs. * The test of Stroop that assesses selective attention During the session 2: * The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs. * The task of the casino (Iowa Gambling Test) * The task of landing * The test of Stroop | Other | compulsive gamblers, healthy volunteers |
Primary outcome
Changement of number of mistake during the words generation test
Time frame: one hour
1 secondary outcome
changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention
Time frame: one hour
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 11 Jun 2015.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Christine Brefel, MD principal investigator
UH Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of word generation and of motivation in people with Parkinson Disease, run by University Hospital, Toulouse 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 11 inclusion and 8 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 11 Jun 2015. 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.
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?
Changement of number of mistake during the words generation test (time frame: one hour). 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 11 Jun 2015.