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临床试验/NCT07702266
NCT07702266尚未招募不适用

Primary Parkinsonian Pain: Clinical Association and Phenotype

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Presence of primary parkinsonian pain according to the 3PDQ questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Parkinsonian patients

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

干预措施: Online self-administered questionnaire (Other)

结局指标

主要结局

Presence of primary parkinsonian pain according to the 3PDQ questionnaire

时间窗: at day 0

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

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

时间窗: at day 0

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

次要结局

  • Presence of anosmia(at day 0)
  • presence of migraines(at day 0)
  • Current antiparkinsonian and analgesic treatments(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)
  • Pain intensity according an EVA scale(at day 0)
  • Presence of comorbidities(at day 0)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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