Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-03 @ 12:17 PM
Study NCT ID:
NCT02364856
Status:
TERMINATED
Last Update Posted:
2019-10-11
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia Nociception Index ANI before and after painful stimulation', 'timeFrame': '300 seconds before and 300 seconds after painful stimulation', 'description': 'ANI is calculated from heart rate recordings 300 seconds before and after painful stimulations and compared'}], 'secondaryOutcomes': [{'measure': 'ANI at baseline', 'timeFrame': '300 seconds at rest', 'description': "ANI calculated from Heart rate recordings during 300 seconds in patient's usual position"}, {'measure': 'time for recovering', 'timeFrame': '10 minutes after painful stimulation', 'description': 'time for recovering baseline ANI after painful stimulation'}, {'measure': 'pain score measured by Visual Analog Scale', 'timeFrame': 'immediately after painful stimulation', 'description': 'when VAS will be applicable, children will be asked to score their pain with VAS scale; results of pain ratings with VAS will be compared to ANI results'}, {'measure': 'pain score measured by rFLACC scale', 'timeFrame': 'immediately after painful stimulation', 'description': 'rFLACC scale will be scored immediately after painful stimulation; results of pain ratings with rFLACC will be compared to ANI results'}, {'measure': 'dysautonomic symptoms', 'timeFrame': 'inclusion', 'description': 'results of ANI measures will be compared between two groups according to presence or absence of dysautonomic symptoms'}, {'measure': 'Gross Motor Function Classification System', 'timeFrame': 'inclusion', 'description': 'results of ANI measures will be compared to the severity of motor impairment through the Gross Motor Function Classification System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autonomic Nervous System', 'Cerebral Palsy', 'Pain', 'Children'], 'conditions': ['Cerebral Palsy', 'Pain', 'Children']}, 'referencesModule': {'references': [{'pmid': '24525906', 'type': 'BACKGROUND', 'citation': 'Jeanne M, Delecroix M, De Jonckheere J, Keribedj A, Logier R, Tavernier B. Variations of the analgesia nociception index during propofol anesthesia for total knee replacement. Clin J Pain. 2014 Dec;30(12):1084-8. doi: 10.1097/AJP.0000000000000083.'}, {'pmid': '22454275', 'type': 'BACKGROUND', 'citation': 'Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.'}, {'pmid': '22256134', 'type': 'BACKGROUND', 'citation': 'De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909.'}, {'pmid': '20973153', 'type': 'BACKGROUND', 'citation': 'Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82. doi: 10.1097/ajp.0b013e3181ed1058.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).', 'detailedDescription': "Cerebral Palsy (CP) is the most common cause of motor handicap in childhood. CP is caused by damage to the developing brain, resulting in limits in movement, posture, or communication ability. CP affects about one newborn on 450. Pain management is one of the major expectations of CP patients (La Foundation Motrice, 2009) but in this population, pain is not recognized and inadequately treated.\n\nAutonomic nervous system (ANS) is the automatic part of our nervous system regulating vital functions like cardiac beats or respiration. It is divided in sympathetic and parasympathetic. Analysis of heart rate variability (HRV) allows isolation of variations due to parasympathetic and their study. Works from the CIC-IT 807 lead to creation of an index called ANI (Analgesia Nociception Index), which is very sensitive to pain. It is validated on adults (Jeanne, 2012). It could be helpful to assess pain in CP, particularly in patients with communication disabilities. It is important to study this new tool in CP children before developing clinical applications.\n\nMain objective of this study is to demonstrate that ANI is relevant in CP children and that it is sensitive to pain like in adults. Population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres. Duration of the study is 2 years. Parent's consent should be obtained. Investigators will record heart rate of children in 3 conditions in their rehabilitation centres: usual position, acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy). Parameters will be calculated in CIC-IT 807 lab (heart rate, ANI). Values of ANI and heart rate before and after painful stimulations will be compared. Correlation between ANI and results of usual pain assessment tools (rFLACC scale, visual analog scale) or characteristics of the population will be analyzed.\n\nLille University Hospital and CIC-IT 807 lab will collaborate with 2 pediatric rehabilitation centers: Centre Marc Sautelet and Zuydcoote Hospital.\n\nExpected result is that ANI is relevant to CP children. Clinical applications are multiple: pain assessment, adaptation of medical equipment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral Palsy\n* Rehabilitation care with physiotherapy and/or toxinum botulinum injections\n* Absence of identified autonomic nervous system disease\n* Parental and children (if applicable) consent obtained\n* French National Health System cover\n\nExclusion Criteria:\n\n* baseline Respiratory Frequency \\> 30/min\n* beta-blockers or atropinic treatment\n* Pacemaker, cardiac rhythm disease\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02364856', 'briefTitle': 'Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.', 'orgStudyIdInfo': {'id': '2013_22'}, 'secondaryIdInfos': [{'id': '2014-A00583-44', 'type': 'OTHER', 'domain': 'ID RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cerebral palsy', 'interventionNames': ['Device: Analgesia Nociception Index']}], 'interventions': [{'name': 'Analgesia Nociception Index', 'type': 'DEVICE', 'description': 'The Analgesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France), based on Heart Rate Variability analysis, measures continuously and non-invasively the influence of Respiratory Sinus Arrhythmia on the heart rate. This 0-100 index indicates the proportion of paraS over sympathetic activity. In adults during surgery under general anesthesia, ANI decreases after painful stimulation and has been related to the balance between analgesia and nociception.\n\nANI is calculated from heart rate recording.', 'armGroupLabels': ['Children with cerebral palsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59650', 'city': "Villeneuve-d'Ascq", 'country': 'France', 'facility': 'Centre de Réadaptation Fonctionnelle Marc Sautelet', 'geoPoint': {'lat': 50.61669, 'lon': 3.16664}}, {'zip': '59123', 'city': 'Zuydcoote', 'country': 'France', 'facility': 'Hôpital maritime de Zuydcoote, Service de SSR Enfant', 'geoPoint': {'lat': 51.06096, 'lon': 2.49338}}], 'overallOfficials': [{'name': 'Justine AVEZ-COUTURIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}, {'name': 'Fondation Motrice', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}