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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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UHToulouse
Toulouse, France
Start Date
December 18, 2018
Primary Completion Date
December 18, 2020
Completion Date
June 18, 2021
Last Updated
January 4, 2019
60
ESTIMATED participants
TCI scale
OTHER
PDQ-39 scale
OTHER
Lead Sponsor
University Hospital, Toulouse
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06113640