Status:
COMPLETED
Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
Lead Sponsor:
Shanghai 10th People's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Postoperative Delirium
Transcranial Magnetic Stimulation, Repetitive
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent...
Eligibility Criteria
Inclusion
- Participants were included if they:
- were 65 years old or older;
- had orthopedic surgery under general anesthesia;
- had normal cognitive function at enrolment \[for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24\];
- were able to complete cognitive assessments and the Confusion Assessment Method (CAM);
- Chinese Mandarin as their native language;
- were willing to participate and being competent to provide informed consent.
- Patients were excluded if they:
- had delirium assessed by CAM before surgery;
- 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);
- had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
- had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
- participating in other clinical studies at the time of screening;
- having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.
Exclusion
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT04661904
Start Date
July 7 2021
End Date
December 13 2024
Last Update
August 15 2025
Active Locations (1)
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1
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China, 200072