- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lise Laclautre
- Numer telefonu: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Lise Laclautre
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Lokalizacje studiów
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Clermont-Ferrand, Francja
- CHU clermont-ferrand
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Główny śledczy:
- Ana MARQUES
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Kontakt:
- Lise Laclautre
- Numer telefonu: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
-
Kontakt:
- Lise Laclautre
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Presence of primary parkinsonian pain according to the 3PDQ questionnaire
Ramy czasowe: 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).
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Presence of anosmia
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RNI 2026 MARQUES
- 2026-A01046-45 (Identyfikator rejestru: n° IDRCB)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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