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临床试验/NCT06080399
NCT06080399已完成不适用

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

University Hospital, Toulouse20 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
20
主要终点
Evaluation of the link between personality dimensions in baseline and QoL amelioration after six months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Evaluation of the link between personality dimensions in baseline and QoL amelioration after six months

时间窗: 6 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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