Primary Parkinsonian Pain: Clinical Association and Phenotype

NCT07702266 | Not Yet Recruiting

• 2 other identifiers: RNI 2026 MARQUES2026-A01046-45
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Consequently, PPP remains difficult to identify, even for clinicians with expertise in Parkinson's disease. Nevertheless, patients with Parkinson's disease who experience PPP appear to exhibit certain demographic and clinical characteristics that may help distinguish them from other patients, including a poorer motor response to levodopa, a stronger association with sleep disturbances, and cognitive and behavioral features such as impulse control disorders (ICDs). PPP may therefore be associated with a specific disease phenotype supported by distinct pathophysiological mechanisms. Recently, a disease progression model proposed the existence of a "Brain-First" subtype (characterized by disease onset in the brainstem) and a "Body-First" subtype (characterized by disease onset in the gastrointestinal system). Several clinical markers appear to distinguish these subtypes, notably the presence of REM sleep behavior disorder (RBD), which has been associated with the Body-First phenotype. The association between PPP and RBD, as well as between PPP and the Body-First subtype, has never been investigated. We hypothesize that PPP may be associated with several clinical markers of the Body-First phenotype. Identifying such associations could facilitate the routine clinical diagnosis of PPP and, consequently, improve its management, which remains inadequate at present. The primary objective is to assess the proportion of patients with primary parkinsonian pain according to the presence of probable RBD in Parkinson's disease. This prospective, cross-sectional, non-interventional category 3 study (RIPH 3) will be conducted in 300 patients. Patients contacted through the France Parkinson Association and interested in participating in the study will be able to access the online questionnaire via a QR code or a web link. Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.

Conditions

Parkinson s Disease

Keywords

Parkinson's disease; RBD; pain

Outcome Measures

Primary Outcomes (2)

• Presence of primary parkinsonian pain according to the 3PDQ questionnaire

  This self-questionnaire is completed by the patient during the inclusion visit

  at day 0

• Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen).

  This self-questionnaire is completed by the patient during the inclusion visit

  at day 0

Secondary Outcomes (9)

• Presence of anosmia

  at day 0

• Presence of constipation

  at day 0

• Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)

  at day 0

• Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)

  at day 0

• Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)

  at day 0

Study Arms (1)

Parkinsonian patients

Patients with a diagnosis of Parkinson's disease confirmed by a neurologist

Other: Online self-administered questionnaire

Interventions

Online self-administered questionnaire OTHER

Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.

Parkinsonian patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be contacted through the France Parkinson Association. If interested in the study, they will be able to access the online questionnaire hosted on the REDCap platform via a QR code or a web link.

You may qualify if:

• Age ≥ 18 years.
• French-speaking.
• Diagnosis of Parkinson's disease confirmed by a neurologist.

You may not qualify if:

• Atypical parkinsonian syndrome.
• Patients under legal protection (guardianship, curatorship, or legal safeguard measures).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Parkinson Disease; Pain

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Lise Laclautre

CONTACT

promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

FR (1)