Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease (PSYCHO-PERF)
January 3, 2019 updated by: University Hospital, Toulouse
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31000
- UHToulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parkinson patients
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients under supervision, curators, or legal guardian
- Patients non-affiliated to a social security
- Patients in exclusion period of another study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
Other Names:
PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
day 1
|
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chrisitine BREFEL COURBON, PH, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2018
Primary Completion (Anticipated)
December 18, 2020
Study Completion (Anticipated)
June 18, 2021
Study Registration Dates
First Submitted
December 21, 2018
First Submitted That Met QC Criteria
January 3, 2019
First Posted (Actual)
January 4, 2019
Study Record Updates
Last Update Posted (Actual)
January 4, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/18/0390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.