Huntington's Disease and Pain

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Другое 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.
• Другое 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).
• Другое 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.

Первичные конечные точки

• The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease [Срок оценки: Baseline assessment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Leiden University Medical Center — Leiden

Публикации

• Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3. PMID 22480803
• Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20. PMID 25330039
• Kunz M, Chatelle C, Lautenbacher S, Rainville P. The relation between catastrophizing and facial responsiveness to pain. Pain. 2008 Nov 15;140(1):127-134. doi: 10.1016/j.pain.2008.07.019. Epub 2008 Sep 9. PMID 18783885
• Kunz M, de Waal MWM, Achterberg WP, Gimenez-Llort L, Lobbezoo F, Sampson EL, van Dalen-Kok AH, Defrin R, Invitto S, Konstantinovic L, Oosterman J, Petrini L, van der Steen JT, Strand LI, de Tommaso M, Zwakhalen S, Husebo BS, Lautenbacher S. The Pain Assessment in Impaired Cognition scale (PAIC15): A multidisciplinary and international approach to develop and test a meta-tool for pain assessment in PMID 31487411
• de Waal MWM, van Dalen-Kok AH, de Vet HCW, Gimenez-Llort L, Konstantinovic L, de Tommaso M, Fischer T, Lukas A, Kunz M, Lautenbacher S, Lobbezoo F, McGuire BE, van der Steen JT, Achterberg WP. Observational pain assessment in older persons with dementia in four countries: Observer agreement of items and factor structure of the Pain Assessment in Impaired Cognition. Eur J Pain. 2020 Feb;24(2):279-2 PMID 31520424
• Sprenger GP, van Velzen M, Achterberg WP, Roos RAC, de Bot ST. Pain processing and pain assessment in Huntington's disease: Study protocol of the Huntington's disease - PAIN study. PLoS One. 2026 Apr 10;21(4):e0346039. doi: 10.1371/journal.pone.0346039. eCollection 2026. PMID 41961860

Идентификаторы

NCT: NCT06693466 · P24.014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗