Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 5:48 AM
Study NCT ID:
NCT02077595
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor evoked potential', 'timeFrame': 'Baseline', 'description': 'measure of intracortical inhibition on abductor pollicis brevis by single-pulse TMS.'}, {'measure': 'Intracortical inhibition, ICI', 'timeFrame': 'Baseline,2 hours, 2.5 hours,and 3 hours', 'description': 'Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.'}, {'measure': 'intracortical facilitation, ICF', 'timeFrame': 'Baseline,Baseline,2 hours, 2.5 hours,and 3 hours', 'description': 'Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transcutaneous electrical nerve stimulation', 'transcranial magnetic stimulation'], 'conditions': ['Transcutaneous Electrical Nerve Stimulation']}, 'descriptionModule': {'briefSummary': 'Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults'}, 'identificationModule': {'nctId': 'NCT02077595', 'briefTitle': 'Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'orgStudyIdInfo': {'id': '101-3624B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '120Hz alternating current stimulation group', 'interventionNames': ['Device: transcutaneous electrical nerve stimulation, TENS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5Hz alternating current stimulation group', 'interventionNames': ['Device: transcutaneous electrical nerve stimulation, TENS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham alternating current stimulation group', 'interventionNames': ['Device: transcutaneous electrical nerve stimulation, TENS']}], 'interventions': [{'name': 'transcutaneous electrical nerve stimulation, TENS', 'type': 'DEVICE', 'description': 'Then participants will receive stimulation for 20 minutes.', 'armGroupLabels': ['120Hz alternating current stimulation group', '5Hz alternating current stimulation group', 'sham alternating current stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung University', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ya-Ju Chang', 'investigatorAffiliation': 'Chang Gung University'}}}}