Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease
时间窗: 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.
次要结局
未报告次要终点
研究者
Susanne T de Bot, MD, PhD
Principal Investigator
Leiden University Medical Center