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Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study
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 patients with genetically confirmed, adult-onset HD, in stage 1 (n=10) and stages 2 - 3 of HD (n = 10).
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 items of an observational pain scale, the Pain Assessment in Impaired Cognition Scale (PAIC15), in patients with HD. * To measure the overall facial expression of pain in patients with HD. * To explore the prevalence and extent of endogenous pain modulation in HD (facilitation, inhibition and the balance between the two). * To make an initial estimate of the measurement error (i.e. agreement), stated as the systematic and random error of a patients' score that is not attributed to true changes in the construct to be measured, for each endpoint related in current study to pain processing in HD (e.g. facial expression and the endogenous pain modulation outcomes). Study design: An experimental, observational, cross-sectional study Study population: The study population will include 20 patients with genetically confirmed, adult-onset HD, in stage 1 (n=10) and stages 2 - 3 of HD (n = 10).
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Leiden University Medical Center
Leiden, South Holland, Netherlands
Start Date
January 1, 2025
Primary Completion Date
December 1, 2025
Completion Date
July 1, 2026
Last Updated
November 18, 2024
20
ESTIMATED participants
Facial expression block
OTHER
Conditioned pain modulation block
OTHER
Pain facilitation block
OTHER
Lead Sponsor
Leiden University Medical Center
Collaborators
NCT06346132
NCT07482709
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07351968