Parkinson DiseasePERSO-PERFNCT06080399
Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 10 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Continuous subcutaneous apomorphine infusion (CSAI)
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Feb 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: parkinson's disease patients receiving CSAI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Chu de Lyon
Bron
Hopital Gabriel Montpied
Clermont-Ferrand
Chu de Grenoble
Grenoble
Chu Limoges
Limoges
Chu de Nancy
Nancy
Chu de Nice
Nice
Chu de Poitiers
Poitiers
Chu de Rennes
Rennes
Chu de Rouen
Rouen
Chu de Toulouse
Toulouse
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Continuous subcutaneous apomorphine infusion (CSAI)
- Keywords
- Parkinson's disease, personality dimensions, TCI, CSAI, second-line treatment, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous subcutaneous apomorphine infusion (CSAI)Other
the CSAI proposed in the usual healthcare pathway of each PD patients included
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start15 Feb 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- ELIVIE France, EVER Pharma France SAS, NHC SAS, France, Orkyn', ETPARK Association, Toulouse, France
- Responsible party
- Sponsor
- Investigators
- CHRISTINE BREFEL COURBON, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080399
- Sponsor's protocol ID
- RC31/23/0401
- Acronym
- PERSO-PERF
- Status last verified
- May 2026
- First submitted
- 6 Oct 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38846534
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06080399
- Acronym / sponsor ID
- PERSO-PERF / RC31/23/0401
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, personality dimensions, TCI, CSAI, second-line treatment, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- ELIVIE France, EVER Pharma France SAS, NHC SAS, France, Orkyn', ETPARK Association, Toulouse, France
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- parkinson's disease patients receiving CSAI
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous subcutaneous apomorphine infusion (CSAI)the CSAI proposed in the usual healthcare pathway of each PD patients included | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 38846534Boussac 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHRISTINE BREFEL COURBON principal investigator
University Hospital, Toulouse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the link between personality dimensions in baseline and QoL amelioration after six months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06080399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.