An observational study in Huntington Disease and Pain, sponsored by Leiden University Medical Center. Not yet recruiting at 1 site in Netherlands. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Leiden University Medical Center · Observational
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:
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).
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's planned enrollment of 20 is below the median of 90 across 78 observational studies indexed under Huntington Disease.
Browse Huntington Disease studies →Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
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Genetically and clinically confirmed adult-onset HD patients (AoHD) (clinical onset ≥ 21 years, CAG repeats ≥ 36, Diagnostic Confidence Level [DCL] of 4]), in stage 1 (n=10 [named as HD 1]), stage 2 and 3 of HD (n = 10 [named as HD 2]), according to the Shoulson-Fahn system. Total Function Capacity (TFC) of the Unified Huntington Disease Rating Scale (UHDRS) will be used to define the HD groups: UHDRS-TFC score 11-13 (stage 1), 7-10 (stage 2), 3-6 (stage 3), 1-2 (stage 4) and a score of 0 (stage 5).
Exclusion Criteria:
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 .
Other: Facial expression block · Other: Conditioned pain modulation block · Other: Pain facilitation block
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 .
Other: Facial expression block · Other: Conditioned pain modulation block · Other: Pain facilitation 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.
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 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.
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.
Time frame: Baseline assessment
Psychometric properties of the Pain Assessment in Impaired Cognition- 15
The intra-, interrater, test-retest reliability and measurement error (i.e. agreement) of the facial expression, body movements and vocalization items of the Pain Assessment in Impaired Cognition - 15 will be assessed. The score of the Pain Assessment in Impaired Cognition - 15 ranges from 0 to 45 points. A score of 4 or higher indicate the presence of possible pain.
Time frame: Baseline assessment - 15 minutes
Overall facial expression of pain in patients with HD
The facial expression will be assessed with the Pain Assessment in Impaired Cognition Scale. The score on the Pain Assessment in Impaired Cognition Scale ranges from 0 to 45 points. A score of 4 or higher indicate the presence of possible pain.
Time frame: Baseline assessment - 15 minutes
Conditioned pain modulation
Pain processing in terms of conditioned pain modulation( pain facilitation, inhibition and the balance between two) will be assessed by the (Computerized) Visual Analogue Scale (CoVAS). The (Computerized) Visual Analogue Scale is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A subject marks a point of the line that matches the amount of pain he or she feels.
Time frame: Baseline assessment - 15 minutes
Conditioned pain modulation
Pain processing in terms of conditioned pain modulation( pain facilitation, inhibition and the balance between two) will be assessed by the numerical rating scale (NRS) in case the Computerized Visual Analogue Scale is not feasible to use. The numerical rating scale consists of a series of numbers rating pain intensity, ranging from 0 to 10, with being 0 being "no pain", and 10 "severe pain".
Time frame: Baseline assessment - 15 minutes
Measurement error Condition Pain Modulation
An initial estimate of the measurement error (i.e. agreement) will be tested for the outcome of the endogenous pain modulation. The (Computerized) Visual Analogue Scale is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A subject marks a point of the line that matches the amount of pain he or she feels. An appropriate analysis will conducted such as (weighted kappa), Intraclass correlation coefficient, SEM and/ or Limits of agreement.
Time frame: Area under the curve; with a time frame 0,1,2,3,4,5,6,7,8,9 to 10 seconds.
Measurement error Condition Pain Modulation
An initial estimate of the measurement error (i.e. agreement) will be tested for the outcome of the endogenous pain modulation. The numerical rating scale consists of a series of numbers rating pain intensity, ranging from 0 to 10, with being 0 being "no pain", and 10 "severe pain". An appropriate analysis will conducted such as (weighted kappa), Intraclass correlation coefficient, SEM and/ or Limits of agreement.
Time frame: Difference in mean score of the Numerical Rating Scale. Numerical Rating Scale is scored directly after the stimulus. The duration of the exposure is 10seconds.
Plan to share: Undecided — Aim is to comply with the standards of the Leiden University Medical Center (LUMC) and the contract of the funder of the study: European Huntington Disease Network (EHDN)
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center