Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-03-15 @ 5:57 PM
Study NCT ID:
NCT02954432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Fregni.felipe@mgh.harvard.edu', 'phone': '6179526158', 'title': 'Felipe Fregni', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3.5 months', 'description': 'Adverse effects were collected with a questionnaire for adverse effects', 'eventGroups': [{'id': 'EG000', 'title': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of active tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of active TUS. During active stimulation the ultrasound will be active for the full 20 minutes.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'tingling', 'notes': 'tingling at the site of stimulation event (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 102, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 74, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Mechanical Temporal Summation (Hand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'OG001', 'title': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '8', 'groupId': 'OG000'}, {'value': '-4', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.', 'unitOfMeasure': 'TSPS percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Conditional Pain Modulation (Hand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'OG001', 'title': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '22', 'groupId': 'OG000'}, {'value': '-4', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.', 'unitOfMeasure': 'CPM percentage changes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'OG001', 'title': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '24', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.', 'unitOfMeasure': 'percentage changes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'FG001', 'title': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA0. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': '40 subjects were enrolled and randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active tDCS + Active TUS - Phase II', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'BG001', 'title': 'Sham tDCS + Sham TUS - Phase II', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).\n\ntranscranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nTranscranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.0', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '17.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'one subject did not declare sex'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline for randomized subjects (phase II)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 1869843, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-25T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase II'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2016-11-02', 'resultsFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-03-25', 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Mechanical Temporal Summation (Hand)', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.'}, {'measure': 'Changes in Conditional Pain Modulation (Hand)', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.'}, {'measure': 'Changes in Pain', 'timeFrame': 'Baseline and 3.5 months', 'description': 'Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['transcranial Direct Current Stimulation', 'Transcranial Ultrasound', 'non-invasive brain stimulation'], 'conditions': ['Chronic Pain', 'Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '34633449', 'type': 'DERIVED', 'citation': 'Teixeira PEP, Pacheco-Barrios K, Uygur-Kucukseymen E, Machado RM, Balbuena-Pareja A, Giannoni-Luza S, Luna-Cuadros MA, Cardenas-Rojas A, Gonzalez-Mego P, Mejia-Pando PF, Wagner T, Dipietro L, Fregni F. Electroencephalography Signatures for Conditioned Pain Modulation and Pain Perception in Nonspecific Chronic Low Back Pain-An Exploratory Study. Pain Med. 2022 Mar 2;23(3):558-570. doi: 10.1093/pm/pnab293.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide informed consent to participate in the study\n2. Subjects between 18 to 85 years old\n3. Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale\n4. Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.\n5. Must have the ability to feel sensation by Von-Frey fiber on the forearm\n\nExclusion Criteria:\n\n1. Subject is pregnant\n2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices\n3. History of alcohol or drug abuse within the past 6 months as self reported\n4. Use of carbamazepine within the past 6 months as self reported\n5. Suffering from severe depression (with a score of \\>30 in the Beck Depression Inventory)\n6. History of neurological disorders as self reported\n7. History of unexplained fainting spells as self reported\n8. History of severe head injury resulting in more than a momentary loss of consciousness as self reported\n9. History of neurosurgery as self reported\n10. Unstable pain\n11. Large placebo responder\n12. Low adherence during the run-in period\n13. Low baseline pain'}, 'identificationModule': {'nctId': 'NCT02954432', 'briefTitle': 'Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NSCLBP).', 'orgStudyIdInfo': {'id': '2016P001956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS + Active TUS', 'description': 'Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).', 'interventionNames': ['Device: transcranial Direct Current Stimulation (tDCS)', 'Device: Transcranial Ultrasound (TUS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS + Sham TUS', 'description': 'Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).', 'interventionNames': ['Device: transcranial Direct Current Stimulation (tDCS)', 'Device: Transcranial Ultrasound (TUS)']}], 'interventions': [{'name': 'transcranial Direct Current Stimulation (tDCS)', 'type': 'DEVICE', 'description': 'Subjects will receive 20 minutes of either active or sham tDCS at an intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.', 'armGroupLabels': ['Active tDCS + Active TUS', 'Sham tDCS + Sham TUS']}, {'name': 'Transcranial Ultrasound (TUS)', 'type': 'DEVICE', 'description': 'Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.', 'armGroupLabels': ['Active tDCS + Active TUS', 'Sham tDCS + Sham TUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Network Research Institute', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Highland Instruments, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Felipe Fregni, MD, PhD, MPH', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}