Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06554067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of tDCS and VNS on Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Patients will be assigned a Study ID that will determine the assigned procedure. At the study's completion the blind will be broken, and data will be turned over for analysis."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain levels using Numerical Rating Scale', 'timeFrame': 'Immediately before the intervention and immediately after the intervention.', 'description': 'Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced.'}, {'measure': 'Pain levels using the Verbal Rating Scale', 'timeFrame': 'Immediately before the intervention and immediately after the intervention.', 'description': 'Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.'}], 'secondaryOutcomes': [{'measure': 'Vital Signs: Blood pressure.', 'timeFrame': 'Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.', 'description': 'Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the blood pressure in mmHg. A high score (higher than 130/80) will indicate a bad outcome.'}, {'measure': 'Vital Signs: Heart rate', 'timeFrame': 'Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.', 'description': 'Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the heart rate before the intervention and after. A result higher than what is physiologic normal (100) will indicate a bad outcome.'}, {'measure': 'Opioid consumption', 'timeFrame': '24 hours after surgery', 'description': 'Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record.'}, {'measure': 'Time from surgery to discharge', 'timeFrame': "From the date of the patient's surgery until the day of the discharge, up to 2 month.", 'description': 'Investigator will measure how long does the patient stay in the hospital after surgery in number of days.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Chronic Pain', 'Transcranial direct current stimulation', 'Vagus nerve stimulation'], 'conditions': ['Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.\n\nStudy outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.\n\nPatients will be divided in the following comparison groups:\n\n* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.\n* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.\n* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.\n* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.', 'detailedDescription': "Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia.\n\nThis study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:\n\n* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.\n* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.\n* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.\n* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.\n\nPatient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia\n\nExclusion Criteria:\n\n* cardiac bradyarrhythmia: taking beta-blockers;\n* patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);\n* pregnancy\n* history of epilepsy or seizures.\n* patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass'}, 'identificationModule': {'nctId': 'NCT06554067', 'briefTitle': 'Effects of tDCS and VNS on Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Effects of tDCS and VNS on Postoperative Analgesia', 'orgStudyIdInfo': {'id': 'AAAV2033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group +/+', 'description': 'Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.', 'interventionNames': ['Device: Active transcranial direct current stimulation', 'Device: Active vagus nerve stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group +/-', 'description': 'Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.', 'interventionNames': ['Device: Active transcranial direct current stimulation', 'Other: Sham vagus nerve stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group -/+', 'description': 'Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.', 'interventionNames': ['Device: Active vagus nerve stimulation', 'Other: Sham transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group -/-', 'description': 'Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.', 'interventionNames': ['Other: Sham transcranial direct current stimulation', 'Other: Sham vagus nerve stimulation']}], 'interventions': [{'name': 'Active transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Ten minutes of active transcranial direct current stimulation', 'armGroupLabels': ['Group +/+', 'Group +/-']}, {'name': 'Active vagus nerve stimulation', 'type': 'DEVICE', 'otherNames': ['VNS'], 'description': 'Ten minutes of active vagus nerve stimulation', 'armGroupLabels': ['Group +/+', 'Group -/+']}, {'name': 'Sham transcranial direct current stimulation', 'type': 'OTHER', 'description': 'Ten minutes of sham tDCS', 'armGroupLabels': ['Group -/+', 'Group -/-']}, {'name': 'Sham vagus nerve stimulation', 'type': 'OTHER', 'description': 'Ten minutes of sham VNS', 'armGroupLabels': ['Group +/-', 'Group -/-']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Paul S. Garcia, MD PhD', 'role': 'CONTACT', 'email': 'pg2618@cumc.columbia.edu', 'phone': '212-304-7523'}, {'name': 'Oriana Lujan, MD', 'role': 'CONTACT', 'email': 'ol2274@cumc.columbia.edu', 'phone': '212-3047523'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared in aggregate form. There is no plan to share individual participant data (IPD) with researchers not involved with the study design. Several posthoc analyses are being planned for retrospective analysis of the data obtained.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology, Division Chief of Neuroanesthesia', 'investigatorFullName': 'Paul Garcia', 'investigatorAffiliation': 'Columbia University'}}}}