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NCT Number: NCT06693466

Huntington's Disease and Pain

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).

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Genetically and clinically confirmed Adult-onset HD patients (≥ 21 years, CAG repeats ≥ 36; DCL of 4).
  • 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.
  • Able to give written informed consent

Exclusion criteria

  • Juvenile and Pediatric Huntington's Disease (age at onset <21 years).
  • Patients in the late stage of the disease (UDHRS-TFC score <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.
  • 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.
  • 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.
  • Women who are pregnant or breastfeeding

Treatment and study plan

Facial expression block

Other

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

Other

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

Other

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.

Primary outcomes

  1. The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease

    Time frame: Baseline assessment

    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.

Other outcomes

  1. Psychometric properties of the Pain Assessment in Impaired Cognition- 15

    Time frame: Baseline assessment - 15 minutes

    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.

  2. Overall facial expression of pain in patients with HD

    Time frame: Baseline assessment - 15 minutes

    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.

  3. Conditioned pain modulation

    Time frame: Baseline assessment - 15 minutes

    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.

  4. Conditioned pain modulation

    Time frame: Baseline assessment - 15 minutes

    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".

  5. Measurement error Condition Pain Modulation

    Time frame: Area under the curve; with a time frame 0,1,2,3,4,5,6,7,8,9 to 10 seconds.

    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.

  6. Measurement error Condition Pain Modulation

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Sprenger, Msc

CONTACT

[email protected]

+31 71 526 54 42

Susanne de Bot, MD, Phd

CONTACT

[email protected]

+31 71 5262197

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • European Huntington's Disease Network

Registry information

Official study title

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

Acronym: HD-P1

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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