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Primary Parkinsonian Pain: Clinical Association and Phenotype (PHENOPAIN)

9 de julio de 2026 actualizado por: University Hospital, Clermont-Ferrand

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.

Descripción general del estudio

Estado

Aún no reclutando

Tipo de estudio

De observación

Inscripción (Estimado)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Parkinsonian patients
Patients with a diagnosis of Parkinson's disease confirmed by a neurologist
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presence of primary parkinsonian pain according to the 3PDQ questionnaire
Periodo de tiempo: at day 0
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).
Periodo de tiempo: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
at day 0

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presence of anosmia
Periodo de tiempo: at day 0
Self-reported olfactory dysfunction
at day 0
Presence of constipation
Periodo de tiempo: at day 0
Self-reported constipation dysfunction
at day 0
Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)
Periodo de tiempo: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
at day 0
Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
Periodo de tiempo: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
at day 0
Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)
Periodo de tiempo: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
at day 0
Pain intensity according an EVA scale
Periodo de tiempo: at day 0
patients will evaluate their pain with an EVA scale at inclusion visit
at day 0
Presence of comorbidities
Periodo de tiempo: at day 0
Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
at day 0
presence of migraines
Periodo de tiempo: at day 0
patient will report if he had migraines
at day 0
Current antiparkinsonian and analgesic treatments
Periodo de tiempo: at day 0
Patient will report his current antiparkinsonian and analgesic treatments
at day 0

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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