Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT04661904
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative delirium', 'timeFrame': '3 days after surgery', 'description': 'Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM).'}, {'measure': 'Cognitive function related to delirium', 'timeFrame': '3 days after surgery', 'description': 'The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily).'}, {'measure': 'Severity of postoperative delirium', 'timeFrame': '3 days after surgery', 'description': 'Severity of postoperative delirium on postoperative day 1, 2 and 3 was defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '3 days after surgery', 'description': 'This was assessed by using Visual Analogue Scale (VAS). The patients scored according to the severity of their pain from no pain (0) to most painful (10).'}, {'measure': 'Sleep quality', 'timeFrame': '3 days after surgery', 'description': 'leep Quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) at baseline (T0), and DSI Daily after surgery.The global PSQI score ranges from 0 to 21, where lower scores denote a healthier sleep quality.'}, {'measure': 'Ability of daily living', 'timeFrame': 'up to 7 days after anesthesia/surgery', 'description': 'This was assessed by using Chinese version of Activity of Daily Living (ADL) Scale.The total score of ADLs ranges from 14 to 56 points and higher ADLs scores indicate lower activities of daily living.'}, {'measure': 'Rate of complication and mortality', 'timeFrame': 'up to 7 days after anesthesia/surgery', 'description': 'Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative delirium', 'continuous theta burst stimulation'], 'conditions': ['Postoperative Delirium', 'Transcranial Magnetic Stimulation, Repetitive']}, 'referencesModule': {'references': [{'pmid': '34400453', 'type': 'DERIVED', 'citation': 'Wei X, Wang M, Ma X, Tang T, Shi J, Zhao D, Yuan T, Xie Z, Shen Y. Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 16;11(8):e048093. doi: 10.1136/bmjopen-2020-048093.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.', 'detailedDescription': 'Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Participants were included if they:\n\n1. were 65 years old or older;\n2. had orthopedic surgery under general anesthesia;\n3. had normal cognitive function at enrolment \\[for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24\\];\n4. were able to complete cognitive assessments and the Confusion Assessment Method (CAM);\n5. Chinese Mandarin as their native language;\n6. were willing to participate and being competent to provide informed consent.\n\nPatients were excluded if they:\n\n1. had delirium assessed by CAM before surgery;\n2. had neurological diseases (e.g., stroke, Parkinson's disease, etc.) according to International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11);\n3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);\n4. had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);\n5. participating in other clinical studies at the time of screening;\n6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke."}, 'identificationModule': {'nctId': 'NCT04661904', 'briefTitle': 'Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium', 'orgStudyIdInfo': {'id': 'dsyy005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cTBS group', 'description': 'Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery.', 'interventionNames': ['Device: Continuous theta burst stimulation (cTBS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': 'Patients randomly assigned to sham group received 9 sessions sham stimulation for total three days after surgery.', 'interventionNames': ['Device: Sham stimulation']}], 'interventions': [{'name': 'Continuous theta burst stimulation (cTBS)', 'type': 'DEVICE', 'description': 'Our active treatment consisted of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. All enrolled patient in the cTBS group received 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1and 2, respectively.', 'armGroupLabels': ['cTBS group']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'The sham stimulation group received a sham cTBS (600 pulses per session, 3 sessions per day, ISI ≥ 30mins, 3 days) with the coil set at 90 against the skull. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1 and 2, respectively.', 'armGroupLabels': ['sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai 10th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yuan Shen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai, Shanghai, China, 200072'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Psychiatry', 'investigatorFullName': 'Yuan Shen, MD, PhD', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}