Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02589093
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2015-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Nociception Monitor in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-04-13', 'releaseDate': '2016-03-15'}, {'resetDate': '2016-10-18', 'releaseDate': '2016-08-23'}, {'resetDate': '2017-01-19', 'releaseDate': '2016-11-25'}], 'estimatedResultsFirstSubmitDate': '2016-03-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2015-10-25', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.', 'timeFrame': 'Assessed during the entire cycle of stimulation (approx. 30 min)', 'description': 'The ANI is an index that can vary from 0 (maximum pain) to 100 (no pain) in humans. The primary objective of this study will be to record the ANI values all along the time period of the clinical evaluation, while the subjects are submitted to standardized electrical stimulation going from 0 mA (no stimulation) to a maximum of 25 mA (or less according to the subject tolerance).\n\nEach stimulation lasts for 3 minutes. During these 3 minutes the ANI is electronically recorded automatically but the Physiodoloris device. The quantitavive value of the index is then analyzed during each stimulation and for all the stimulations.\n\nThis will allow to evaluate whether it exists any correlation between the ANI values and the intensity of the electrical stimulation.'}], 'secondaryOutcomes': [{'measure': 'ANI correlation with Numerical Rating Scale (NRS) of pain', 'timeFrame': 'Assessed during the entire cycle of stimulation (approx. 30 min)', 'description': 'NRS and ANI absolute values will be recorded all along the study duration (approx. 30min). This will allow to evaluate a likely correlation between the ANI absolute values and the NRS values.'}, {'measure': 'Heart rate correlation with ANI', 'timeFrame': 'Assessed during the entire cycle of stimulation (approx. 30 min)', 'description': 'ANI values and HR are recorded for the whole duration of the study. A correlation between these two criteria will be evaluated to know if HR increases (more pain) when ANI decreases (more pain).'}, {'measure': 'Blood pressure correlation with ANI', 'timeFrame': 'Assessed during the entire cycle of stimulation (approx. 30 min)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Analgesia', 'Monitoring', 'Analgesia Nociception Index', 'ANI', 'PhysioDoloris', 'Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '28432612', 'type': 'DERIVED', 'citation': 'Issa R, Julien M, Decary E, Verdonck O, Fortier LP, Drolet P, Richebe P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'Anesthesiology daily practice consists in management of sedation, immobility and analgesia. The monitoring of this last component remains largely based on indirect signs with poor sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an increased demand for more accurate analgesia monitors. Several parameters have been studied in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic tones, and is therefore influenced by pain and analgesia.\n\nMDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index, the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number indicating less parasympathetic tone. It has been shown in previous studies under general anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and to increase with opioids administration.\n\nThe purpose of this study is to show a correlation between the variation of the ANI with pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of increasing intensity. The investigators hypothesize that an increasing pain score will correlate with decreasing ANI values.', 'detailedDescription': 'See above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers aged 18-80 years old\n\nExclusion Criteria:\n\n* Heart disease\n* Neurological disease\n* Allergy to cutaneous electrodes\n* Chronic pain and/or chronic analgesics consumption\n* Medication affecting the autonomic nervous system\n* Inability to understand a numeric rating scale (NRS)'}, 'identificationModule': {'nctId': 'NCT02589093', 'briefTitle': 'Validation of a Nociception Monitor in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Validation of a Nociception Monitor in Healthy Volunteers', 'orgStudyIdInfo': {'id': '14074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stimulation', 'description': 'Subjects will receive progressive electrical stimulations with an external nerve stimulator over the ulnar nerve, from 0 mA to 30 mA in increments of 5 (2 Hz single twitch mode), for 3 minutes at each intensity. They will be asked to score their pain level (NRS 0-10) every minute. ANI will be recorded constantly.', 'interventionNames': ['Device: Stimulation']}], 'interventions': [{'name': 'Stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Stimulation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philippe Richebé, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Philippe Richebé', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-15', 'type': 'RELEASE'}, {'date': '2016-04-13', 'type': 'RESET'}, {'date': '2016-08-23', 'type': 'RELEASE'}, {'date': '2016-10-18', 'type': 'RESET'}, {'date': '2016-11-25', 'type': 'RELEASE'}, {'date': '2017-01-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Philippe Richebé, M.D., Maisonneuve-Rosemont Hospital'}}}}