Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-03 @ 3:26 PM
Study NCT ID:
NCT02837458
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Frequency Electrical Currents in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Mechanical Pain Threshold', 'timeFrame': 'baseline at 0 min', 'description': 'The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton'}, {'measure': 'Baseline Tactile Threshold', 'timeFrame': 'baseline at 0 min', 'description': 'The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton'}, {'measure': 'Baseline Muscle Strength', 'timeFrame': 'Baseline at 0 min', 'description': 'The muscle strength will be measured with a dynamometer and will be expressed in Newton'}, {'measure': 'Mechanical Pain Threshold after treatment at 30 min', 'timeFrame': 'Immediately after treatment at 30 min', 'description': 'The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton'}, {'measure': 'Tactile Threshold after treatment at 30 min', 'timeFrame': 'Immediately after treatment at 30 min', 'description': 'The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton'}, {'measure': 'Muscle Strength after treatment at 30 min', 'timeFrame': 'Immediately after treatment at 30 min', 'description': 'The muscle strength will be measured with a dynamometer and will be expressed in Newton'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Mechanical Pain Threshold', 'timeFrame': 'baseline at 0 min, immediately after treatment at 30 min', 'description': 'The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton'}, {'measure': 'Change from baseline in TactileThreshold', 'timeFrame': 'baseline at 0 min, immediately after treatment at 30 min', 'description': 'The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton'}, {'measure': 'Change from baseline in Muscle strength', 'timeFrame': 'baseline at 0 min, immediately after treatment at 30 min', 'description': 'The muscle strength will be measured with a dynamometer and will be expressed in Newton'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electric current', 'Nerve block', 'somatosensory evaluation'], 'conditions': ['High Frequency Current']}, 'referencesModule': {'references': [{'pmid': '32075666', 'type': 'DERIVED', 'citation': 'Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.', 'detailedDescription': 'In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).\n\nIt has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.\n\nOnly one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Neuromuscular disease.\n* Epilepsy.\n* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.\n* Osteosynthesis material in the upper limb.\n* Diabetes.\n* Cancer.\n* Cardiovascular disease.\n* Pacemaker or other implanted electrical device.\n* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.\n* Presence of tattoos or other external agent introduced into the treatment or assessment area.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02837458', 'briefTitle': 'Effect of High Frequency Electrical Currents in Healthy Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'ddsm18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Frequency', 'description': 'Transcutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.', 'interventionNames': ['Device: High-Frequency']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stimulation', 'description': 'Electrodes are placed over the arm for a 30 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.', 'interventionNames': ['Device: Sham Stimulation']}], 'interventions': [{'name': 'High-Frequency', 'type': 'DEVICE', 'description': 'high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)', 'armGroupLabels': ['High-Frequency']}, {'name': 'Sham Stimulation', 'type': 'DEVICE', 'description': 'Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)', 'armGroupLabels': ['Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Diego Serrano-Muñoz', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Diego Serrano-Muñoz, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional de Parapléjicos, Toledo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Nacional de Parapléjicos de Toledo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}