Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03082820
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2017-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092184', 'term': 'Nerve Conduction Studies'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-12', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N1-latency', 'timeFrame': '1 day', 'description': 'N1-latency of pain-related evoked potentials in ms'}], 'secondaryOutcomes': [{'measure': 'N1P1-amplitude', 'timeFrame': '1 day', 'description': 'Amplitude of pain-related evoked potentials in µV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Nerve Injuries']}, 'descriptionModule': {'briefSummary': 'The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral Nerve Injury\n\nExclusion Criteria:\n\n* Polyneuropathy\n* Contralateral peripheral nerve injury\n* Severe psychiatric disorders\n* Disorders affecting central nervous system'}, 'identificationModule': {'nctId': 'NCT03082820', 'briefTitle': 'Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain', 'orgStudyIdInfo': {'id': 'PREP2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and nerve conduction studies (NCS) were performed with patients with peripheral nerve injury.', 'interventionNames': ['Diagnostic Test: Pain-related evoked potentials (PREP)', 'Diagnostic Test: Quantitative Sensory Testing (QST)', 'Diagnostic Test: Nerve conduction studies (NCS)']}, {'label': 'Controls', 'description': 'Pain-related evoked potentials (PREP) and Quantitative Sensory Testing (QST) were performed with healthy adults.', 'interventionNames': ['Diagnostic Test: Pain-related evoked potentials (PREP)', 'Diagnostic Test: Quantitative Sensory Testing (QST)']}], 'interventions': [{'name': 'Pain-related evoked potentials (PREP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Quantitative Sensory Testing (QST)', 'type': 'DIAGNOSTIC_TEST', 'description': 'QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Nerve conduction studies (NCS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'NCS were performed with patients only.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christoph Maier, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Bergmannsheil Bochum'}]}, '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'}}}}