- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07702266
Primary Parkinsonian Pain: Clinical Association and Phenotype (PHENOPAIN)
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lise Laclautre
- 전화번호: +33473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 연락처 백업
- 이름: Lise Laclautre
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 장소
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Clermont-Ferrand, 프랑스
- CHU clermont-ferrand
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수석 연구원:
- Ana MARQUES
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연락하다:
- Lise Laclautre
- 전화번호: +33473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
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연락하다:
- Lise Laclautre
- 이메일: promo_interne_drci@chu-clermontferrand.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Parkinsonian patients
Patients with a diagnosis of Parkinson's disease confirmed by a neurologist
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Presence of primary parkinsonian pain according to the 3PDQ questionnaire
기간: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen).
기간: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Presence of anosmia
기간: at day 0
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Self-reported olfactory dysfunction
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at day 0
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Presence of constipation
기간: at day 0
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Self-reported constipation dysfunction
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at day 0
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Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)
기간: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
기간: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)
기간: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Pain intensity according an EVA scale
기간: at day 0
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patients will evaluate their pain with an EVA scale at inclusion visit
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at day 0
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Presence of comorbidities
기간: at day 0
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Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
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at day 0
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presence of migraines
기간: at day 0
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patient will report if he had migraines
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at day 0
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Current antiparkinsonian and analgesic treatments
기간: at day 0
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Patient will report his current antiparkinsonian and analgesic treatments
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at day 0
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RNI 2026 MARQUES
- 2026-A01046-45 (레지스트리 식별자: n° IDRCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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