Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT03752502
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Pre-test (before tDCS)', 'description': 'Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.\n\nThe VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.'}, {'measure': 'Depression', 'timeFrame': 'Pre-test (before tDCS)', 'description': 'Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.\n\nThe BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose intensity varies from 0 to 3 (higher scores indicating more depressive symptoms).'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'Pre-test (before tDCS)', 'description': 'Catastrophizing pain scale that we tracked as possible confounding factor.\n\nThe pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness.\n\nThe total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.'}], 'primaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Pre and Post-test (immediately after tDCS)', 'description': 'Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'Pre and Post-test (immediately after tDCS)', 'description': 'Conditioned pain modulation paradigms consist of the evaluation of a painful test stimulus followed by a second evaluation either at the same time as a distant, painful conditioning stimulus.\n\nPPT will be evaluated following a conditioning stimulus condition (hand immersion in a cold water).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The Neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. However, their effects on pain modulation systems and clinical outcomes are lacking.\n\nThis study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure pain threshold and conditioned pain modulation in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects without medical complaints.\n\nExclusion Criteria:\n\nConcurrent medication likely to affect cognitive performance pregnancy or possible pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3 months) history of seizure or stroke.'}, 'identificationModule': {'nctId': 'NCT03752502', 'briefTitle': 'Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Piauí'}, 'officialTitle': 'Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.', 'orgStudyIdInfo': {'id': '1.584.966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerebral stimulation', 'description': 'Active transcranial direct current stimulation\n\ntDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).', 'interventionNames': ['Procedure: Transcranial direct current stimulation (tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Combined stimulation', 'description': 'Active transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)\n\ntDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).\n\nPES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.', 'interventionNames': ['Procedure: Transcranial direct current stimulation (tDCS)', 'Procedure: Peripheral electrical stimulation (PES)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham cerebral stimulation', 'description': 'Sham transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)\n\ntDCS: 20 minutes (30s ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).', 'interventionNames': ['Procedure: Sham tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral stimulation', 'description': 'Active peripheral electrical stimulation (PES).\n\nPES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.', 'interventionNames': ['Procedure: Peripheral electrical stimulation (PES)', 'Procedure: Sham tDCS']}], 'interventions': [{'name': 'Transcranial direct current stimulation (tDCS)', 'type': 'PROCEDURE', 'description': 'Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.', 'armGroupLabels': ['Cerebral stimulation', 'Combined stimulation']}, {'name': 'Peripheral electrical stimulation (PES)', 'type': 'PROCEDURE', 'description': 'Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.', 'armGroupLabels': ['Combined stimulation', 'Peripheral stimulation']}, {'name': 'Sham tDCS', 'type': 'PROCEDURE', 'description': 'Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.', 'armGroupLabels': ['Peripheral stimulation', 'Sham cerebral stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64202020', 'city': 'Parnaíba', 'state': 'Piauí', 'country': 'Brazil', 'facility': 'Department of Physical Therapy. Federal University of Piaui', 'geoPoint': {'lat': -2.90472, 'lon': -41.77667}}], 'overallOfficials': [{'name': 'Fuad Hazime, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Piaui'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Piauí', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Physical Therapy Department', 'investigatorFullName': 'Fuad Ahmad Hazime', 'investigatorAffiliation': 'Universidade Federal do Piauí'}}}}