Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-01-31
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Synaptic Density and Progression of Huntington's Disease.
NCT04701580
Clinicopathological MRI and CSF Correlates in Huntington's Disease.
NCT05534139
Longitudinal SV2A and MRI in Premanifest HD
NCT06626412
Increasing Sensori-Motor Rhythm Activity by EEG-Neurofeedback to Reduce the Impact of Pain on Daily Functioning
NCT06234917
Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
NCT00670709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adult-onset HD stage 1
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 .
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.
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).
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.
Adult-onset HD stage 2-3
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 .
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.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Huntington's Disease Network
NETWORK
Leiden University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susanne T de Bot, MD, PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susanne de Bot, MD Phd
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gregory Sprenger, Msc
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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 impaired cognition, especially dementia. Eur J Pain. 2020 Jan;24(1):192-208. doi: 10.1002/ejp.1477. Epub 2019 Oct 13.
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):279-296. doi: 10.1002/ejp.1484. Epub 2019 Oct 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P24.014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.