Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease

Parkinson Disease Clinical Trial

— PSYCHO-PERF  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03793491
• Other study ID #: RC31/18/0390
• Status: Active, not recruiting
• Start date: December 18, 2018
• Est. completion date: June 18, 2021

Study information

• Verified date: January 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 the subthalamic nucleus (STN) or continuous infusion).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 18, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• TCI scale
TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
• PDQ-39 scale
PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1
Primary	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	6 months