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

• ClinicalTrials.gov Identifier: NCT03793491
• Recruitment Status: Unknown
• First Posted: January 4, 2019
• Last Update Posted: January 4, 2019
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Parkinson Disease	Other: TCI scale; Other: PDQ-39 scale

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

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: December 18, 2018
• Estimated Primary Completion Date: December 18, 2020
• Estimated Study Completion Date: June 18, 2021

Groups and Cohorts

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.

Other: TCI scale; TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.; Other Names: Temperament and Character Inventory scale (TCI); Quality of life scale; Other: PDQ-39 scale; PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.; Other Name: Parkinson's Disease Questionnaire (PDQ-39)

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Parkinson patients

Criteria

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.

Contacts and Locations

Locations

France

UHToulouse

Toulouse, France, 31000

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

• Principal Investigator: Chrisitine BREFEL COURBON, PH; University Hospital, Toulouse

More Information

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT03793491
• Other Study ID Numbers: RC31/18/0390
• First Posted: January 4, 2019
• Last Update Posted: January 4, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:

continuous infusion; personality

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases