Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease
NCT ID: NCT06080399
Last Updated: 2024-08-29
Study Results
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Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2024-02-15
2026-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Continuous subcutaneous apomorphine infusion (CSAI)
the CSAI proposed in the usual healthcare pathway of each PD patients included
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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ELIVIE France
UNKNOWN
EVER Pharma France SAS
UNKNOWN
NHC SAS, France
UNKNOWN
Orkyn'
INDUSTRY
ETPARK Association, Toulouse, France
UNKNOWN
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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CHRISTINE BREFEL COURBON
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RC31/23/0401
Identifier Type: -
Identifier Source: org_study_id
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