Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 6:45 PM
Study NCT ID:
NCT06693466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huntington's Disease and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychometric properties of the Pain Assessment in Impaired Cognition- 15', 'timeFrame': 'Baseline assessment - 15 minutes', 'description': '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.\n\nThe 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.'}, {'measure': 'Overall facial expression of pain in patients with HD', 'timeFrame': 'Baseline assessment - 15 minutes', 'description': 'The facial expression will be assessed with the Pain Assessment in Impaired Cognition Scale.\n\nThe 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.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'Baseline assessment - 15 minutes', 'description': '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).\n\nThe (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.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'Baseline assessment - 15 minutes', 'description': 'Pain processing in terms of conditioned pain modulation( pain facilitation, inhibition and the balance between two) will be assessed by the numerical rating scale (NRS) in case the Computerized Visual Analogue Scale is not feasible to use.\n\nThe numerical rating scale consists of a series of numbers rating pain intensity, ranging from 0 to 10, with being 0 being "no pain", and 10 "severe pain".'}, {'measure': 'Measurement error Condition Pain Modulation', 'timeFrame': 'Area under the curve; with a time frame 0,1,2,3,4,5,6,7,8,9 to 10 seconds.', 'description': 'An initial estimate of the measurement error (i.e. agreement) will be tested for the outcome of the endogenous pain modulation.\n\nThe (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.\n\nAn appropriate analysis will conducted such as (weighted kappa), Intraclass correlation coefficient, SEM and/ or Limits of agreement.'}, {'measure': 'Measurement error Condition Pain Modulation', 'timeFrame': 'Difference in mean score of the Numerical Rating Scale. Numerical Rating Scale is scored directly after the stimulus. The duration of the exposure is 10seconds.', 'description': 'An initial estimate of the measurement error (i.e. agreement) will be tested for the outcome of the endogenous pain modulation.\n\nThe numerical rating scale consists of a series of numbers rating pain intensity, ranging from 0 to 10, with being 0 being "no pain", and 10 "severe pain".\n\nAn appropriate analysis will conducted such as (weighted kappa), Intraclass correlation coefficient, SEM and/ or Limits of agreement.'}], 'primaryOutcomes': [{'measure': "The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease", 'timeFrame': 'Baseline assessment', 'description': "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.\n\nThe comprehension of the instructions, duration and the completion of the study are examples of items which will be evaluated."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Huntington's disease', 'Pain', 'Pain processing', 'Pain facilitation', 'Pain inhibition', 'Pain Assessment in Impaired Cognition (PAIC15)'], 'conditions': ['Huntington Disease', 'Pain']}, 'referencesModule': {'references': [{'pmid': '22480803', 'type': 'BACKGROUND', 'citation': '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': '25330039', 'type': 'BACKGROUND', 'citation': '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': '18783885', 'type': 'BACKGROUND', 'citation': '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': '31487411', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31520424', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nThe exploratory objectives are:\n\n* 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.\n* To measure the overall facial expression of pain in patients with HD.\n* To explore the prevalence and extent of endogenous pain modulation in HD (facilitation, inhibition and the balance between the two).\n* 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).\n\nStudy design: An experimental, observational, cross-sectional study\n\nStudy 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Genetically and clinically confirmed Adult-onset HD patients (≥ 21 years, CAG repeats ≥ 36; DCL of 4).\n2. 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.\n3. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Juvenile and Pediatric Huntington's Disease (age at onset \\<21 years).\n2. Patients in the late stage of the disease (UDHRS-TFC score \\<3).\n3. 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.\n4. 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.\n5. 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.\n6. Women who are pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT06693466', 'acronym': 'HD-P1', 'briefTitle': "Huntington's Disease and Pain", 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': "Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study", 'orgStudyIdInfo': {'id': 'P24.014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult-onset HD stage 1', 'description': 'The adult-onset HD stage 1 group (total function capacity 11-13) include 10 participants.\n\nThe subjects will be undergo three different pain test batteries .', 'interventionNames': ['Other: Facial expression block', 'Other: Conditioned pain modulation block', 'Other: Pain facilitation block']}, {'label': 'Adult-onset HD stage 2-3', 'description': 'The adult-onset HD stage 2-3 group (total function capacity 3-10) include 10 participants.\n\nThe subjects will be undergo three different pain test batteries .', 'interventionNames': ['Other: Facial expression block', 'Other: Conditioned pain modulation block', 'Other: Pain facilitation block']}], 'interventions': [{'name': 'Facial expression block', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Adult-onset HD stage 1', 'Adult-onset HD stage 2-3']}, {'name': 'Conditioned pain modulation block', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Adult-onset HD stage 1', 'Adult-onset HD stage 2-3']}, {'name': 'Pain facilitation block', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Adult-onset HD stage 1', 'Adult-onset HD stage 2-3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'contacts': [{'name': 'Gregory Sprenger, Msc', 'role': 'CONTACT', 'email': 'g.p.sprenger@lumc.nl', 'phone': '+31 71 526 54 42'}, {'name': 'Susanne de Bot, MD, Phd', 'role': 'CONTACT', 'email': 'huntingtononderzoek@lumc.nl', 'phone': '+31 715262197'}, {'name': 'Gregory Sprenger, Msc', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Gregory Sprenger, Msc', 'role': 'CONTACT', 'email': 'g.p.sprenger@lumc.nl', 'phone': '+31 71 526 54 42'}, {'name': 'Susanne de Bot, MD, Phd', 'role': 'CONTACT', 'email': 'huntingtononderzoek@lumc.nl', 'phone': '+31 71 5262197'}], 'overallOfficials': [{'name': 'Susanne de Bot, MD Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "European Huntington's Disease Network", 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susanne T de Bot, MD, PhD', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}