Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease
PERSO-PERF
Could Psycho-bio-social Context and Personality be a Predictive Factor of Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease Patients? - PERSO-PERF Study
1 other identifier
observational
70
1 country
10
Brief Summary
Since our previous study has shown that some personality dimensions were associated with Quality of Life (QoL) amelioration after Deep Brain Stimulation (DBS) in Parkinson's disease (PD), the investigators aim to evaluate the impact of personality dimensions on therapeutic response after another second-line treatment: the continuous subcutaneous apomorphine infusion (CSAI). Moreover, the investigators would like to evaluate the potential evolution of personality dimensions through CSAI. The investigators also aim to evaluate other bio-psycho-social factors (representations of the disease, ways of copying and social support) influence on QoL amelioration after DBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2024
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 29, 2024
August 1, 2024
2.1 years
October 6, 2023
August 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the link between personality dimensions in baseline and QoL amelioration after six months
to evaluate the link between personality dimensions in baseline and QoL amelioration after six months of CSAI in PD patients, the coefficients of linear regressions between the scores of the different TCI personality dimensions at V0 (explicative variables) and the percentage of global QoL amelioration (Total PDQ-39 scores) (response variable) at V6 will be calculated
6 months
Interventions
the CSAI proposed in the usual healthcare pathway of each PD patients included
Eligibility Criteria
parkinson's disease patients receiving CSAI
You may qualify if:
- Parkinson's disease patients as defined by the United Kingdom Parkinson's disease Brain Bank (UKPDSBB) criteria and aged from 40 to 75 years old (included)
- Patients with motor fluctuations and/or invalidating dyskinesia and awaiting CSAI establishment in the context of their usual care for PD
- Patients affiliated to a social security system
You may not qualify if:
- Patients presenting an atypical parkinsonian syndrome Patients having a Deep Brain Stimulation
- Patients with a psychiatric disease such as bipolar disorder or delusions linked to a dopaminergic psychosis
- Patients under guardianship, curatorship or safeguard of justice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- ELIVIE Francecollaborator
- EVER Pharma France SAScollaborator
- NHC SAS, Francecollaborator
- Orkyn'collaborator
- ETPARK Association, Toulouse, Francecollaborator
Study Sites (10)
Chu de Lyon
Bron, France
Hopital Gabriel Montpied
Clermont-Ferrand, France
Chu de Grenoble
Grenoble, France
Chu Limoges
Limoges, France
Chu de Nancy
Nancy, France
Chu de Nice
Nice, France
Chu de Poitiers
Poitiers, France
Chu de Rennes
Rennes, France
Chu de Rouen
Rouen, France
Chu de Toulouse
Toulouse, France
Related Publications (1)
Boussac M, Harroch E, Barthelemy C, Ory-Magne F, Leung C, Fabbri M, Arbus C, Brefel-Courbon C. Personality and quality-of-life improvement after apomorphine infusion in Parkinson's disease. Brain Commun. 2024 May 24;6(3):fcae181. doi: 10.1093/braincomms/fcae181. eCollection 2024.
PMID: 38846534RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHRISTINE BREFEL COURBON
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2023
First Posted
October 12, 2023
Study Start
February 15, 2024
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
August 29, 2024
Record last verified: 2024-08