Parkinson DiseasePSYCHO-PERFNCT03793491
Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- TCI scale and PDQ-39 scale
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2018to 18 Jun 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson patients
Who may be able to join
- Patients having Parkinson's disease according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
- All Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease
- Patient able to give its free and informed consent
- Patient having a social security
Who cannot join
- Patients presenting atypical Parkinson's syndrome
- Patients having a deep brain stimulation
- Patient having a psychiatric disease such as: mood disorders, psychotic disorder…
- Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24
- None ability to give its consent
- Patients unable to realize the tests provided in the context of this study
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- Patients under supervision, curators, or legal guardian
- Patients non-affiliated to a social security
- Patients in exclusion period of another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study About Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs (by Subcutaneous Apomorphine Infusion or Intrajejunal Infusion of Levodopa-carbidopa), in Parkinson's Disease
The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).
Read the detailed description
Parkinson's disease leads to quality of life degradation, especially at level of motor complications. Second line treatment can be proposed to patients. There are deep brain stimulation and two treatments by continuous perfusion: subcutaneous apomorphine infusion and intrajejunal infusion of levodopa-carbidopa. These treatments allow improvement of end-of-dose akinesia, dyskinesia, and a diminution of treatments per os. Nonetheless, they also lead to some side effects and complications. Currently, there are no scientific data to compare the efficacy of these two techniques on motor and non-motor symptoms. Choice is made according to the profile of the patient mainly based on side effects risks, and practitioner's habits. There are still no predictive factors clearly defined to judge of the best efficacy of these treatments according to the patients. Moreover, in an additional study named PSYCHO-STIM, the investigator have discovered that personality can be a predictive factor of quality of life amelioration 1 year after deep brain stimulation. It's why the investigator would like to test personality as a predictive factor of therapeutic response after both continuous perfusions that are available for the patients. Thus, patients beginning a treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa will be included. The investigator will evaluate their personality with the questionnaire "TCI" (Temperament and Character Inventory) and the investigator will assess their quality of life (PDQ-39), looking for the percentage of amelioration 6 months after the treatment by continuous infusion started. As secondary criteria, depression (HAMD), anxiety (HAMA), apathy (LARS), motility (MDS-UPDRS) and clinic severity (CGIS) will also be accessed before the treatment change and six months later.
- Conditions
- Parkinson Disease
- Being tested
- TCI scale, PDQ-39 scale
- Keywords
- continuous infusion, personality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI scaleOther
Also called Temperament and Character Inventory scale (TCI), Quality of life scale
TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
PDQ-39 scaleOther
Also called Parkinson's Disease Questionnaire (PDQ-39)
PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients having Parkinson's disease | Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale. Receives: Other: TCI scale; Other: PDQ-39 scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment
Measured: day 1
percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Dec 2018
- Primary completion18 Dec 2020 (estimated)
- Study completion18 Jun 2021 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrisitine BREFEL COURBON, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793491
- Sponsor's protocol ID
- RC31/18/0390
- Acronym
- PSYCHO-PERF
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2018
- Last updated
- 4 Jan 2019
- 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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs (by Subcutaneous Apomorphine Infusion or Intrajejunal Infusion of Levodopa-carbidopa), in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03793491
- Acronym / sponsor ID
- PSYCHO-PERF / RC31/18/0390
- Conditions
- Parkinson Disease
- Keywords
- continuous infusion, personality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 18 Dec 2020 (estimated)
- Study completion
- 18 Jun 2021 (estimated)
- First posted
- 4 Jan 2019 (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.
The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).
Detailed description
Parkinson's disease leads to quality of life degradation, especially at level of motor complications. Second line treatment can be proposed to patients. There are deep brain stimulation and two treatments by continuous perfusion: subcutaneous apomorphine infusion and intrajejunal infusion of levodopa-carbidopa. These treatments allow improvement of end-of-dose akinesia, dyskinesia, and a diminution of treatments per os. Nonetheless, they also lead to some side effects and complications. Currently, there are no scientific data to compare the efficacy of these two techniques on motor and non-motor symptoms. Choice is made according to the profile of the patient mainly based on side effects risks, and practitioner's habits. There are still no predictive factors clearly defined to judge of the best efficacy of these treatments according to the patients. Moreover, in an additional study named PSYCHO-STIM, the investigator have discovered that personality can be a predictive factor of quality of life amelioration 1 year after deep brain stimulation. It's why the investigator would like to test personality as a predictive factor of therapeutic response after both continuous perfusions that are available for the patients. Thus, patients beginning a treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa will be included. The investigator will evaluate their personality with the questionnaire "TCI" (Temperament and Character Inventory) and the investigator will assess their quality of life (PDQ-39), looking for the percentage of amelioration 6 months after the treatment by continuous infusion started. As secondary criteria, depression (HAMD), anxiety (HAMA), apathy (LARS), motility (MDS-UPDRS) and clinic severity (CGIS) will also be accessed before the treatment change and six months later.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having Parkinson's disease | – | Other: TCI scale, Other: PDQ-39 scaleParkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson patients
Key inclusion criteria (4 listed)
- Patients having Parkinson's disease according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
- All Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease
- Patient able to give its free and informed consent
- Patient having a social security
Key exclusion criteria (9 listed)
- Patients presenting atypical Parkinson's syndrome
- Patients having a deep brain stimulation
- Patient having a psychiatric disease such as: mood disorders, psychotic disorder…
- Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24
- None ability to give its consent
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 |
|---|---|---|
| TCI scaleAlso: Temperament and Character Inventory scale (TCI), Quality of life scaleTCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started. | Other | Patients having Parkinson's disease |
| PDQ-39 scaleAlso: Parkinson's Disease Questionnaire (PDQ-39)PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion. | Other | Patients having Parkinson's disease |
Primary outcome
percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
Time frame: day 1
Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment
percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
Time frame: 6 months
Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- 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.
Chrisitine BREFEL COURBON, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 9 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 4 Jan 2019. 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?
Results are not available in the source record.
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?
percent of improvement of quality of life score at 6 months after the beginning of the second line treatment (time frame: day 1). The study lists 2 primary outcomes in all. 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 4 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.