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

Last updated: August 27, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Continuous subcutaneous apomorphine infusion (CSAI)

Clinical Study ID

NCT06080399
RC31/23/0401
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Parkinson's disease patients as defined by the United Kingdom Parkinson's diseaseBrain Bank (UKPDSBB) criteria and aged from 40 to 75 years old (included)

  • Patients with motor fluctuations and/or invalidating dyskinesia and awaiting CSAIestablishment in the context of their usual care for PD

  • Patients affiliated to a social security system

Exclusion

Exclusion Criteria:

  • Patients presenting an atypical parkinsonian syndrome Patients having a Deep BrainStimulation

  • Patients with a psychiatric disease such as bipolar disorder or delusions linked toa dopaminergic psychosis

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

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

  • Patients under guardianship, curatorship or safeguard of justice

  • Patients under exclusion period from another study

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Continuous subcutaneous apomorphine infusion (CSAI)
Phase:
Study Start date:
February 15, 2024
Estimated Completion Date:
April 01, 2026

Study 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.

Connect with a study center

  • Chu de Lyon

    Bron,
    France

    Active - Recruiting

  • Hopital Gabriel Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Chu de Grenoble

    Grenoble,
    France

    Active - Recruiting

  • Chu Limoges

    Limoges,
    France

    Active - Recruiting

  • Chu de Nancy

    Nancy,
    France

    Active - Recruiting

  • Chu de Nice

    Nice,
    France

    Active - Recruiting

  • Chu de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • Chu de Rennes

    Rennes,
    France

    Active - Recruiting

  • Chu de Rouen

    Rouen,
    France

    Active - Recruiting

  • Chu de Toulouse

    Toulouse,
    France

    Active - Recruiting

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