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Huntington's Disease and Pain (HD-P1) 20 Internazionale

Non ancora in arruolamento
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La sperimentazione clinica NCT06693466 (HD-P1) è uno studio osservazionale per Malattia di Huntington, Dolore, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 gennaio 2025, con l'obiettivo di raggiungere 20 partecipanti. Sotto la guida di l'Università di Leida, dovrebbe concludersi entro il 1 luglio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 18 novembre 2024.
Sommario breve
The primary objective of this pilot study is to assess the feasibility of three internationally agreed pain test batteries in patients with Huntington Disease. The pain test batteries are developed to collect data about the facial expression of pain, body movements and vocalization of (non-) painful stimuli, and to collect data for testing the pain inhibition and facilitation. The study population will include 20 pat...Mostra di più
Descrizione dettagliata

The primary objective of this pilot study is to assess the feasibility of a comprehensive experimental design with three internationally well-known experimental pain protocols in patients with Huntington Disease.

The exploratory objectives are:

  • To explore the psychometric properties (inter-, intra-rater and test-retest reliability and measurement error) of the facial expression, body movements and vocalization it...
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Titolo ufficiale

Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study

Patologie
Malattia di HuntingtonDolore
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • HD-P1
  • P24.014
Numero NCT
NCT06693466
Data di inizio (effettiva)
2025-01
Ultimo aggiornamento pubblicato
2024-11-18
Data di completamento (stimata)
2026-07
Arruolamento (previsto)
20
Tipo di studio
Osservazionale
Stato
Non ancora in arruolamento
Parole chiave
Huntington's disease
Pain
Pain processing
Pain facilitation
Pain inhibition
Pain Assessment in Impaired Cognition (PAIC15)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Adult-onset HD stage 1
The adult-onset HD stage 1 group (total function capacity 11-13) include 10 participants. The subjects will be undergo three different pain test batteries .
Facial expression block
Data will be collected to assess the facial expression, body movements and vocalization of (non-) painful heat stimuli. The experiment includes individually tailored and randomly administered painful (perceived as moderate pain) and non-painful heat stimuli.
Conditioned pain modulation block
The conditioned pain modulation will be tested according to internationally agreed standards and includes a painful phasic heat (test stimulus) and a painful tonic cold stimulus (conditioning stimulus).
Pain facilitation block
Pain facilitation will be assessed by using painful mechanical pinprick stimuli. The magnitude of pain experienced after a single mechanical pinprick stimulus is compared to that of a train of 10 pinprick stimuli of the same force.
Adult-onset HD stage 2-3
The adult-onset HD stage 2-3 group (total function capacity 3-10) include 10 participants. The subjects will be undergo three different pain test batteries .
Facial expression block
Data will be collected to assess the facial expression, body movements and vocalization of (non-) painful heat stimuli. The experiment includes individually tailored and randomly administered painful (perceived as moderate pain) and non-painful heat stimuli.
Conditioned pain modulation block
The conditioned pain modulation will be tested according to internationally agreed standards and includes a painful phasic heat (test stimulus) and a painful tonic cold stimulus (conditioning stimulus).
Pain facilitation block
Pain facilitation will be assessed by using painful mechanical pinprick stimuli. The magnitude of pain experienced after a single mechanical pinprick stimulus is compared to that of a train of 10 pinprick stimuli of the same force.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease
A screening tool was developed to determine whether the comprehensive experimental design, with three various experimental pain protocols, is feasible in patients with HD. After each assessment, the screening tool will be scored. Each item of the screening tool represents an important part of the experimental pain protocol. A 'cut-off' score ranging from 60% to 80% was adopted for each item, indicating the minimum score to be met to consider as feasible for that specific part of the experimental pain protocol. The comprehension of the instructions, duration and the completion of the study are examples of items which will be evaluated.
Baseline assessment
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
21 Years
Sessi idonei
Tutti
  1. Genetically and clinically confirmed Adult-onset HD patients (≥ 21 years, CAG repeats ≥ 36; DCL of 4).
  2. Good general health apart from having HD. Note: Patients with chronic illness (e.g. hypertension) will be eligible if the illness is stable and well-controlled according to the investigator that will not impact the primary objectives of the study.
  3. Able to give written informed consent

  1. Juvenile and Pediatric Huntington's Disease (age at onset <21 years).
  2. Patients in the late stage of the disease (UDHRS-TFC score <3).
  3. Have medical, psychiatric, or other conditions (other than HD) that, according to the investigator, may compromise the patient's ability to understand the patient information sheet, to give informed consent, to comply with all study requirements, or to perform study assessments.
  4. Have a history of (in the past year) or current (ab)use of any drug, alcohol or medication that, in the opinion of the investigator, may seriously interfere with the primary objectives of the study.
  5. The presence of a sensorimotor neuropathy or any another disturbance significantly disturbing the somatosensory systems, based on medical history and/or clinical examination, that can interfere with the pain test battery.
  6. Women who are pregnant or breastfeeding
Leiden University Medical Center logoUniversità di Leida
European Huntington's Disease Network logoEuropean Huntington's Disease Network
Parte responsabile dello studio
Susanne T de Bot, MD, PhD, Investigatore principale, Principal Investigator, Leiden University Medical Center
Contatti principali dello studio
Contatto: Gregory Sprenger, Msc, +31 71 526 54 42, [email protected]
Contatto: Susanne de Bot, MD, Phd, +31 71 5262197, [email protected]
1 Centri dello studio in 1 paesi

South Holland

Leiden University Medical Center, Leiden, South Holland, 2333 ZA, Netherlands
Gregory Sprenger, Msc, Contatto, +31 71 526 54 42, [email protected]
Susanne de Bot, MD, Phd, Contatto, +31 715262197, [email protected]
Gregory Sprenger, Msc, Contatto