Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-18 @ 1:31 AM
Study NCT ID:
NCT02241967
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Dependent Effects of tDCS on Post-Operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jeffrey.Borckardt@va.gov', 'phone': '843-792-3295', 'title': 'Jeffrey Borckardt, Ph.D', 'organization': 'Ralph H. Johnson VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2-Days during the routine post-operative hospital stay; the duration in which tDCS was delivered.', 'eventGroups': [{'id': 'EG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sham tDCS', 'description': 'no active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Opioid Pain Medication Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG003', 'title': 'Sham tDCS', 'description': 'no active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.99', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '31.12', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '28.65', 'spread': '31.12', 'groupId': 'OG002'}, {'value': '33.15', 'spread': '5.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-Days', 'description': 'Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.', 'unitOfMeasure': 'mg of morphine equivalent dose (MED)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient-reported Pain Intensity Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'OG003', 'title': 'Sham tDCS', 'description': 'no active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.33', 'spread': '.44', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '.43', 'groupId': 'OG001'}, {'value': '5.84', 'spread': '.48', 'groupId': 'OG002'}, {'value': '5.33', 'spread': '.56', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-Days', 'description': 'Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Average Pain Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments\n\n4 Real sessions of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.'}, {'id': 'OG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments\n\n2 Real Sessions of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.'}, {'id': 'OG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment\n\n1 Real Session of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.'}, {'id': 'OG003', 'title': 'Sham tDCS', 'description': 'no active treatments\n\nSham Transcranial Direct Current Stimulation: Four sessions of sham tDCS; control intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '.46', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '.72', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '.74', 'groupId': 'OG002'}, {'value': '4.89', 'spread': '.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "10-worst pain imaginable."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments administered at 2mA for 20minutes each sessions, two the day of surgery and two the day after surgery.\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'FG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments administered at 2mA for 20minutes each sessions. 2 real sessions the day of surgery and 2 sham sessions the day after surgery.\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'FG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment administered at 2mA for 20minutes for the first session immediately following surgery, then 1 sham session later, day of surgery, and 2 sham sessions the day after surgery.\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'FG003', 'title': 'Sham tDCS', 'description': 'no active treatments. All 4 sessions were sham tDCS. 2 delivered day of surgery, 2 delivered day after surgery.\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'tDCS Full Dose', 'description': '4 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'BG001', 'title': 'tDCS Half Dose', 'description': '2 active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'BG002', 'title': 'tDCS Minimal Dose', 'description': '1 active treatment\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'BG003', 'title': 'Sham tDCS', 'description': 'no active treatments\n\nTranscranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '8.95', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '7.93', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '8.14', 'groupId': 'BG003'}, {'value': '64.7', 'spread': '8.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Procedure Type', 'classes': [{'categories': [{'title': 'Total Knee Arthroplasty (TKA)', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'Total Hip Arthroplasty (THA)', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-08', 'size': 619457, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-23T15:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-24', 'studyFirstSubmitDate': '2014-09-02', 'resultsFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-10', 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Opioid Pain Medication Dose', 'timeFrame': '2-Days', 'description': 'Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.'}, {'measure': 'Patient-reported Pain Intensity Ratings', 'timeFrame': '2-Days', 'description': 'Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported Average Pain Ratings', 'timeFrame': '6 Months', 'description': 'Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "10-worst pain imaginable."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'pain', 'post-surgical pain', 'opioid', 'transcranial direct current stimulation', 'tDCS', 'brain stimulation', 'total hip arthroplasty', 'TKA', 'THA'], 'conditions': ['Total Knee Arthroplasty (Postoperative Pain)', 'Total Hip Arthroplasty(Postoperative Pain)']}, 'descriptionModule': {'briefSummary': 'The proper control of acute and chronic pain is one of the most important areas in health care. Despite the profound advances in neuroscience over the past 20 years, the investigators still largely use opiate narcotics, much as was done in the Civil War. Total knee arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery time and hospital length of stay. New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions. In two independent preliminary pilot studies, the Investigators have shown that tDCS can reduce post-operative PCA use by as much as 46% while simultaneously reducing subjective pain ratings. The present study aims to determine the effects of transcranial direct current stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and post-surgical complications during the 48-hour post-operative period following total knee arthroplasty.', 'detailedDescription': 'The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS. Real tDCS was administered at 2mA whereas sham tDCS delivered none.\n\n120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have 4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 - 1 session of real tDCS (+ 3 sham-sessions). Group 4 is "Sham" tDCS, which does not involve any real stimulation. The participants will receive 2 tDCS treatments on the day of their surgery, and 2 tDCS treatments the day after their surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.\n\n* Between the ages of 19 and 90\n* Mentally capable of reading, writing, giving consent, and following instructions\n* Cleared for and scheduled for unilateral TKA or THA surgery\n\nExclusion Criteria:\n\n* Implanted medical devices above the waist\n* Pregnant\n* History of seizures\n* Allergic to latex rubber\n* Psychiatric conditions other than for depression and/or anxiety disorders'}, 'identificationModule': {'nctId': 'NCT02241967', 'acronym': 'tDCS-TKA', 'briefTitle': 'Dose Dependent Effects of tDCS on Post-Operative Pain', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Dose Dependent Effects of tDCS on Post-Operative Pain', 'orgStudyIdInfo': {'id': 'CLIN-005-13F'}, 'secondaryIdInfos': [{'id': 'CX001078', 'type': 'OTHER_GRANT', 'domain': 'Charleston CSR&D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS Full Dose', 'description': '4 active treatments', 'interventionNames': ['Device: 4 Real sessions of Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS Half Dose', 'description': '2 active treatments', 'interventionNames': ['Device: 2 Real Sessions of Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS Minimal dose', 'description': '1 active treatment', 'interventionNames': ['Device: 1 Real Session of Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'no active treatments', 'interventionNames': ['Device: Sham Transcranial Direct Current Stimulation']}], 'interventions': [{'name': '4 Real sessions of Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS Full Dose'], 'description': 'Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.', 'armGroupLabels': ['tDCS Full Dose']}, {'name': '2 Real Sessions of Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS Half Dose'], 'description': 'Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.', 'armGroupLabels': ['tDCS Half Dose']}, {'name': '1 Real Session of Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS Minimal Dose'], 'description': 'Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.', 'armGroupLabels': ['tDCS Minimal dose']}, {'name': 'Sham Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['Sham tDCS'], 'description': 'Four sessions of sham tDCS; control intervention.', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401-5799', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center, Charleston, SC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Jeffrey J Borckardt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, SC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}