- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06080399
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: CHRISTINE BREFEL COURBON
- Phone Number: +33 (0)5 61 77 25 35
- Email: christine.brefel-courbon@univ-tlse3.fr
Study Contact Backup
- Name: ESTELLE HARROCH
- Email: harroch.e@chu-toulouse.fr
Study Locations
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Bron, France
- Recruiting
- Chu de Lyon
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Contact:
- STEPHANE THOBOIS
- Email: stephane.thobois@chu-lyon.fr
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Clermont-Ferrand, France
- Recruiting
- Hôpital Gabriel Montpied
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Contact:
- ANA MARQUES
- Email: ar_marques@chu-clermontferrand.fr
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Grenoble, France
- Recruiting
- CHU de GRENOBLE
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Contact:
- ELENA MORO
- Email: emoro@chu-grenoble.fr
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Limoges, France
- Recruiting
- CHU Limoges
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Contact:
- JEAN-LUC HOUETO
- Email: Jean-Luc.HOUETO@chu-limoges.fr
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Nancy, France
- Recruiting
- Chu de Nancy
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Contact:
- SOLENE FRISMAND
- Email: s.frismand@chru-nancy.fr
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Nice, France
- Recruiting
- CHU de Nice
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Contact:
- CAROLINE GIORDANA
- Email: GIORDANA.C@chu-nice.fr
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Poitiers, France
- Recruiting
- CHU de Poitiers
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Contact:
- ISABELLE BENATRU
- Email: Isabelle.BENATRU@chu-poitiers.fr
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Rennes, France
- Recruiting
- CHU de Rennes
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Contact:
- SOPHIE DRAPIER
- Email: Sophie.Drapier@chu-rennes.fr
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Rouen, France
- Recruiting
- Chu de Rouen
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Contact:
- DAVID MALTETE
- Email: David.Maltete@chu-rouen.fr
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Toulouse, France
- Recruiting
- CHU de Toulouse
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Contact:
- CHRISTINE BREFEL COURBON
- Email: christine.brefel-courbon@univ-tlse3.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the link between personality dimensions in baseline and QoL amelioration after six months
Time Frame: 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
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: CHRISTINE BREFEL COURBON, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- RC31/23/0401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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