Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05673720
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2022-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gmartorella@fsu.edu', 'phone': '850-645-9758', 'title': 'Geraldine Martorella, Hyochol Ahn', 'organization': 'Florida State University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'we had fNIRS malfunction at the beginning of the study and did not include cortical activity as an outcome in this study'}}, 'adverseEventsModule': {'timeFrame': 'from baseline up to one month', 'description': 'questionnaire after each session + self-report to research assistant during study regarding serious and adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analgesic Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'OG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3 after surgery', 'description': 'The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'OG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.18', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '2.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3 after surgery', 'description': 'The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'OG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.04', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '3.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3 after surgery', 'description': 'It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being "does not interfere" (0) and "completely interferes" (10). A total interference score can also be calculated by taking the sum of all the items (score range 0-70). A higher score reflects worse outcomes : higher pain interference with activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-4 (PHQ-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'OG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3 after surgery', 'description': 'The PHQ-4 has a total score range of 0-12, which is broken down into four ranges: normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) psychological distress. For the subscales (PHQ-2 for depression and GAD-2 for anxiety), the score range is 0-6. higher values represent a worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing Scale (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'OG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.56', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '25.25', 'spread': '13.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3 after surgery', 'description': "to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4). The total score range for the Pain Catastrophizing Scale (PCS) is 0 to 52, where a higher score indicates greater levels of pain catastrophizing.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied for 20 minutes X 5 sessions.'}, {'id': 'FG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered for 20 minutes X 5 sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'May 2023 and February 2024. Participants were recruited at their preoperative visit. A clinician or a research coordinator from the clinic conducted a pre-screening of potentially eligible participants, and introduced the study to potential participants at their preoperative visit. If the individual agreed to learn more, the PI or RA entered the room to discuss study, answer questions and scheduled an appointment.', 'preAssignmentDetails': 'A total of 40 potential participants were approached. Of these, 8 (20%) did not meet inclusion criteria (e.g., partial replacement surgery, fibromyalgia) and 8 declined to participated (20%) mainly because they were living too far to travel to the lab for the baseline and last appointments before surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preoperative Active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.'}, {'id': 'BG001', 'title': 'Preoperative Sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'multiple ethnicity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-07', 'size': 305510, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-10T15:33', 'hasProtocol': True}, {'date': '2025-10-10', 'size': 21227, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-12T17:28', 'hasProtocol': False}, {'date': '2023-06-19', 'size': 261284, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-25T13:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2022-12-19', 'resultsFirstSubmitDate': '2025-10-15', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-12', 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic Consumption', 'timeFrame': 'day 3 after surgery', 'description': 'The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'day 3 after surgery', 'description': 'The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'day 3 after surgery', 'description': 'It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being "does not interfere" (0) and "completely interferes" (10). A total interference score can also be calculated by taking the sum of all the items (score range 0-70). A higher score reflects worse outcomes : higher pain interference with activities.'}, {'measure': 'Patient Health Questionnaire-4 (PHQ-4)', 'timeFrame': 'day 3 after surgery', 'description': 'The PHQ-4 has a total score range of 0-12, which is broken down into four ranges: normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) psychological distress. For the subscales (PHQ-2 for depression and GAD-2 for anxiety), the score range is 0-6. higher values represent a worse outcome'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'day 3 after surgery', 'description': "to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4). The total score range for the Pain Catastrophizing Scale (PCS) is 0 to 52, where a higher score indicates greater levels of pain catastrophizing."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty', 'detailedDescription': 'The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective unilateral knee total replacement\n* mentally capable of reading, giving consent and following instructions\n* being able to answer questions in English\n* not pregnant\n\nExclusion Criteria:\n\n* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation\n* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia\n* alcohol/substance abuse\n* current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists\n* hospitalization within the preceding year for psychiatric illness\n* no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision'}, 'identificationModule': {'nctId': 'NCT05673720', 'briefTitle': 'Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '00003476'}, 'secondaryIdInfos': [{'id': '140009-140', 'type': 'OTHER_GRANT', 'domain': 'Florida State University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative active tDCS+MBI', 'description': 'Active tDCS with simultaneous meditation intervention will be applied.', 'interventionNames': ['Device: active tDCS paired with active MBM']}, {'type': 'SHAM_COMPARATOR', 'label': 'preoperative sham tDCS+MBI', 'description': 'Sham tDCS with simultaneous sham MBM intervention will be delivered.', 'interventionNames': ['Device: sham tDCS paired with sham MBM']}], 'interventions': [{'name': 'active tDCS paired with active MBM', 'type': 'DEVICE', 'description': 'Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.', 'armGroupLabels': ['preoperative active tDCS+MBI']}, {'name': 'sham tDCS paired with sham MBM', 'type': 'DEVICE', 'description': 'For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.', 'armGroupLabels': ['preoperative sham tDCS+MBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Orthopedic Clinic', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Geraldine Martorella', 'investigatorAffiliation': 'Florida State University'}}}}