Clinical trial NCT05713500: Comparative Study of Personality in Parkinson's Disease Patients With Other Chronic Pain
Official title: Personality and Chronic Pain: a Comparative Study in Parkinson's Disease and Other Chronic Pain Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Chronic pain
personality
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinsonian patients with and without chronic pain and non-parkinsonian patients with chronic pain such as fibromyalgia and headache

Brief summary: The present study compare personality of Parkinson's Disease (PD) patients with chronic, PD patients without pain and non-parkinsonian patients with other chronic pain condition.

Detailed description: The present study would like to compare personality dimensions from the Temperament and character inventory (TCI) in four groups of patients: PD patients with chronic pain related to PD, PD patients without pain and non-PD patients with chronic pain such as fibromyalgia or chronic headache. Our aim is to evaluate if PD patients with chronic pain related to PD have a different personality than PD patients without pain and to see if this personality is specific to PD.

Eligibility criteria: Inclusion Criteria:

* PD patients:

Patients having Parkinson's disease according to UNITED KINGDOM PARKINSON'S DISEASE SOCIETY BRAIN BANK (UKPDSBB) criteria

PD patients with chronic pain:

Patients with a pain VAS score ≥ 4 (mean VAS for the last week) Patients with a chronic pain since at least 3 months

PD patients without pain:

Patients with a pain VAS score \< 3

* non PD patients:

Patients with chronic headache:

Patients with chronic headache according to the ICHD-3 beta criteria Patients with a chronic pain since at least 3 months

Patients with fibromyalgia:

Patients with fibromyalgia according to the criteria of the American College of Rheumatology 2016 (Wolfe et al., 2016) Patients with a pain VAS score ≥ 4 (mean VAS for the last week) Patients with a chronic pain since at least 3 months

* All patients:

Patient \> 18 years old Patient able to give its free and informed consent Patient having a social security.

Exclusion Criteria:

* PD patients:

Patients presenting atypical Parkinson's syndrome Patients having a deep brain stimulation Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24

* All patients:

Patient having a psychiatric disease diagnosed according to the Diagnostic and Statistical Manual-V (DSM-V) criteria such as mood disorders, psychotic disorder... None ability to give its consent Patients unable to realize the tests provided in the context of this study Patients under supervision, curatorship, or legal guardian Patients non-affiliated to a social security Patients in exclusion period of another study.

Primary outcomes:
measure: TCI personality dimensions between the two groups of patients
timeFrame: 24 months
Secondary outcomes:
measure: personality dimensions of the TCI and two-by-two analyses
timeFrame: 24 months
measure: association between personality the seven TCI and scores
timeFrame: 24 months
measure: association between personality the seven TCI personality dimensions and different pain
timeFrame: 24 months
measure: association of personality dimensions of the TCI and in other patients with chronic pain etiology
timeFrame: 24 months
measure: exploratory objective
timeFrame: 24 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
Study officials:
affiliation: University Hospital, Toulouse
name: Christine BREFEL-COURBON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: