Huntington Disease, Pain
Conditions
Keywords
Huntington's disease, Pain, Pain processing, Pain facilitation, Pain inhibition, Pain Assessment in Impaired Cognition (PAIC15)
Brief summary
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).
Detailed description
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).
Interventions
OTHERFacial 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.
OTHERConditioned 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).
OTHERPain 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.
Sponsors
European Huntington's Disease Network
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Genetically and clinically confirmed Adult-onset HD patients (≥ 21 years, CAG repeats ≥ 36; DCL of 4). 2. 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. 3. Able to give written informed consent
Exclusion criteria
1. Juvenile and Pediatric Huntington's Disease (age at onset \<21 years). 2. Patients in the late stage of the disease (UDHRS-TFC score \<3). 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. 4. 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. 5. 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. 6. Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease | 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
| Measure | Time frame | Description |
|---|---|---|
| Psychometric properties of the Pain Assessment in Impaired Cognition- 15 | 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. |
| Overall facial expression of pain in patients with HD | 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. |
| Conditioned pain modulation | 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. |
| Measurement error Condition Pain Modulation | 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. |
Countries
Netherlands
Contacts
Primary ContactGregory Sprenger, Msc
Backup ContactSusanne de Bot, MD, Phd
Outcome results
None listed