Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT03237650
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2017-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2017-07-30', 'studyFirstSubmitQcDate': '2017-07-30', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief', 'timeFrame': 'during the measurement', 'description': 'pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)'}, {'measure': 'N1P1-amplitude', 'timeFrame': 'during the measurement', 'description': 'Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV'}], 'secondaryOutcomes': [{'measure': 'N1-latency', 'timeFrame': 'during the measurement', 'description': 'Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec'}, {'measure': 'P0N1-amplitude', 'timeFrame': 'during the measurement', 'description': 'Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Painful cutaneous electrical stimulation', 'Conditioned Pain Modulation'], 'conditions': ['Habituation']}, 'descriptionModule': {'briefSummary': 'Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* any kind of disease'}, 'identificationModule': {'nctId': 'NCT03237650', 'briefTitle': 'Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?', 'orgStudyIdInfo': {'id': 'PCES-Hab'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christoph Maier, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Christoph Maier, Prof. Dr.', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}