Huntington DiseaseHD-P1NCT06693466
Huntington's Disease and Pain
An observational study of Huntington Disease and Pain, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Huntington Disease, Pain
- What is being tested?
- Facial expression block, Conditioned pain modulation block and Pain facilitation block
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Genetically and clinically confirmed adult-onset HD patients (AoHD) (clinical onset ≥ 21 years, CAG repeats ≥ 36, Diagnostic Confidence Level [DCL] of 4]), in stage 1 (n=10 [named as HD 1]), stage 2 and 3 of HD (n = 10 [named as HD 2]), according to the Shoulson-Fahn system. Total Function Capacity (TFC) of the Unified Huntington Disease Rating Scale (UHDRS) will be used to define the HD groups: UHDRS-TFC score 11-13 (stage 1), 7-10 (stage 2), 3-6 (stage 3), 1-2 (stage 4) and a score of 0 (stage 5).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Gregory Sprenger, Msc, +31 71 526 54 42, g.p.sprenger@lumc.nl
Susanne de Bot, MD, Phd, +31 715262197, huntingtononderzoek@lumc.nl
About this study
Official title: Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study
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).
Read the 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).
- Conditions
- Huntington Disease, Pain
- Being tested
- Facial expression block, Conditioned pain modulation block, Pain facilitation block
- Keywords
- Huntington's disease, Pain, Pain processing, Pain facilitation, Pain inhibition, Pain Assessment in Impaired Cognition (PAIC15)
- Medical subject headings
- Huntington Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial expression blockOther
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 blockOther
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 blockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: Facial expression block; Other: Conditioned pain modulation block; Other: Pain facilitation block | |
| 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 . Receives: Other: Facial expression block; Other: Conditioned pain modulation block; Other: Pain facilitation block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease
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.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Huntington's Disease Network
- Responsible party
- Principal investigator, Susanne T de Bot, MD, PhD, Leiden University Medical Center
- Investigators
- Susanne de Bot, MD Phd, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693466
- Sponsor's protocol ID
- P24.014
- Acronym
- HD-P1
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aim is to comply with the standards of the Leiden University Medical Center (LUMC) and the contract of the funder of the study: European Huntington Disease Network (EHDN)
Publications
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.
PubMed 22480803Yarnitsky 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.
PubMed 25330039Kunz 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.
PubMed 18783885Kunz 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.
PubMed 31487411de 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.
PubMed 31520424Sprenger 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.
PubMed 41961860
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study
- ClinicalTrials.gov ID
- NCT06693466
- Acronym / sponsor ID
- HD-P1 / P24.014
- Conditions
- Huntington Disease, Pain
- Keywords
- Huntington's disease, Pain, Pain processing, Pain facilitation, Pain inhibition, Pain Assessment in Impaired Cognition (PAIC15)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- European Huntington's Disease Network
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult-onset HD stage 1 | – | Other: Facial expression block, Other: Conditioned pain modulation block, Other: Pain facilitation blockThe adult-onset HD stage 1 group (total function capacity 11-13) include 10 participants. The subjects will be undergo three different pain test batteries . |
| Adult-onset HD stage 2-3 | – | Other: Facial expression block, Other: Conditioned pain modulation block, Other: Pain facilitation blockThe 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 . |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Genetically and clinically confirmed adult-onset HD patients (AoHD) (clinical onset ≥ 21 years, CAG repeats ≥ 36, Diagnostic Confidence Level [DCL] of 4]), in stage 1 (n=10 [named as HD 1]), stage 2 and 3 of HD (n = 10 [named as HD 2]), according to the Shoulson-Fahn system. Total Function Capacity (TFC) of the Unified Huntington Disease Rating Scale (UHDRS) will be used to define the HD groups: UHDRS-TFC score 11-13 (stage 1), 7-10 (stage 2), 3-6 (stage 3), 1-2 (stage 4) and a score of 0 (stage 5).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial expression blockData 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. | Other | Adult-onset HD stage 1, Adult-onset HD stage 2-3 |
| Conditioned pain modulation blockThe 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). | Other | Adult-onset HD stage 1, Adult-onset HD stage 2-3 |
| Pain facilitation blockPain 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. | Other | Adult-onset HD stage 1, Adult-onset HD stage 2-3 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 22480803Yarnitsky 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.
- Background: PubMed 25330039Yarnitsky 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.
- Background: PubMed 18783885Kunz 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.
- Background: PubMed 31487411Kunz 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.
- Background: PubMed 31520424de 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.
- Derived from this study: PubMed 41961860Sprenger 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.
- Individual participant dataSharing planned: Undecided. Aim is to comply with the standards of the Leiden University Medical Center (LUMC) and the contract of the funder of the study: European Huntington Disease Network (EHDN)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne de Bot, MD Phd principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease and Pain, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Sprenger, Msc (+31 71 526 54 42, g.p.sprenger@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.