Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease

Parkinson Disease Clinical Trial

— PERSO-PERF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080399
• Other study ID #: RC31/23/0401
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: CHRISTINE BREFEL COURBON
• Phone: (0)5 61 77 25 35
• Email: christine.brefel-courbon[@]univ-tlse3.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

As Parkinson's disease (PD) progresses, the onset of motor and non-motor fluctuations alters patients Quality of Life (QoL). Second-line treatments can then be proposed: either the implantation of deep brain electrodes (Deep Brain Stimulation of the Sub-Thalamic Nuclei (DBS-STN)), or the drug approach (continuous subcutaneous infusion of apomorphine or continuous intrajejunal infusion of levodopa/carbidopa).

To date, no randomized double-blind trial has compared the efficacy and adverse effects of these different types of second-line treatments. There is therefore no clearly defined predictive factor that could predict better efficacy of these second-line treatments in patients, or the occurrence of adverse effects leading to discontinuation of these treatments.

The choice of treatment must consider patients specific personal needs as well as their clinical phenotype, this constitutes the major challenge of personalized medicine. Thus, personality, which reflects the way a person thinks, reflects, acts and behaves in different situations, appears to be a possible predictive criterion for QoL improvement after second-line treatments.

Indeed, using the Temperament and Character Inventory (TCI) self-questionnaire, the investigators have shown that two personality dimensions of the TCI ("Novelty Seeking" and "Cooperativeness") appeared to be predictive of QoL amelioration in PD patients after DBS-STN. Thus, the use of this personality questionnaire, the TCI, enables better prediction of patients therapeutic response after DBS-STN. It could also be useful to predict therapeutic response after other second-line treatments such as continuous subcutaneous infusion of apomorphine. In this study, the investigators therefore propose to evaluate the impact of personality dimensions on therapeutic response after the introduction of this infusion therapy.

Investigators carried out a preliminary exploratory study (PSYCHO-PERF study - ClinicalTrials.gov NCT03793491) which showed a significant association between a personality dimension of the TCI ("Reward Dependence") and QoL improvement after six months of continuous subcutaneous infusion of apomorphine in 33 PD patients (article in preparation). This suggests that patients with high Reward Dependence scores may be good candidates for continuous subcutaneous infusion of apomorphine. However, these results need to be confirmed on a larger scale, by means of a multicenter study.

Hence, some TCI personality dimensions in PD patients could be predictive of QoL improvement after second-line treatment. Thus, before proposing a second-line treatment, in the context of personalized medicine, personality assessment could be one of the criteria to choose between these different treatments.

However, the investigators are aware that PD patients personality can only partly explain the therapeutic response. For this reason, the investigators also wish to include in our study other psycho-bio-social factors (social representations of the disease and treatments, coping strategies and social support perceived by patients) that may influence QoL improvement following treatment.

In a more exploratory context, the investigators would also like to assess changes in TCI personality dimensions of PD patients following treatment with continuous subcutaneous infusion of apomorphine, since changes in mood and/or behavior have already been observed. If a change is observed, the investigators will determine whether this change is associated with clinical and demographic data prior to the continuous infusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 presenting a cognitive deficit attested by a score to the Montreal Cognitive Assessment inferior to 24, solely during the inclusion (baseline - V0)

• Patient with a serious pathology (e.g. cancer) or a health condition which could interfere with the assessment of their quality of life, at the discretion of the investigator upon inclusion

• Patients under guardianship, curatorship or safeguard of justice

• Patients under exclusion period from another study

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Continuous subcutaneous apomorphine infusion (CSAI)
the CSAI proposed in the usual healthcare pathway of each PD patients included

Locations

Country	Name	City	State
France	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

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Toulouse	ELIVIE France, ETPARK Association, Toulouse, France, EVER Pharma France SAS, NHC SAS, France, Orkyn'

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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