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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Lise Laclautre
- 電話番号:+33473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
研究連絡先のバックアップ
- 名前:Lise Laclautre
- メール:promo_interne_drci@chu-clermontferrand.fr
研究場所
-
-
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Clermont-Ferrand、フランス
- CHU clermont-ferrand
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主任研究者:
- Ana MARQUES
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コンタクト:
- Lise Laclautre
- 電話番号:+33473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
-
コンタクト:
- Lise Laclautre
- メール:promo_interne_drci@chu-clermontferrand.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of primary parkinsonian pain according to the 3PDQ questionnaire
時間枠:at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
|
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).
時間枠:at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of anosmia
時間枠:at day 0
|
Self-reported olfactory dysfunction
|
at day 0
|
|
Presence of constipation
時間枠:at day 0
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Self-reported constipation dysfunction
|
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)
時間枠: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)
時間枠:at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
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Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)
時間枠:at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
|
Pain intensity according an EVA scale
時間枠: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
時間枠:at day 0
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Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
|
at day 0
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presence of migraines
時間枠: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
時間枠:at day 0
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Patient will report his current antiparkinsonian and analgesic treatments
|
at day 0
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RNI 2026 MARQUES
- 2026-A01046-45 (レジストリ識別子:n° IDRCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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