Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

Tongji University

Status: Completed

Conditions: Transcranial Magnetic Stimulation, Repetitive; Postoperative Delirium

Treatments: Device: Sham stimulation; Device: Continuous theta burst stimulation (cTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04661904

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Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 324 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participants were included if they:

1. were 65 years old or older;
2. had orthopedic surgery under general anesthesia;
3. 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];
4. were able to complete cognitive assessments and the Confusion Assessment Method (CAM);
5. Chinese Mandarin as their native language;
6. were willing to participate and being competent to provide informed consent.

Patients were excluded if they:

1. had delirium assessed by CAM before surgery;
2. 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);
3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
4. had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
5. participating in other clinical studies at the time of screening;
6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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324 participants in 2 patient groups

cTBS group

Experimental group

Description:

Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery.

Treatment:

Device: Continuous theta burst stimulation (cTBS)

sham group

Sham Comparator group

Description:

Patients randomly assigned to sham group received 9 sessions sham stimulation for total three days after surgery.

Treatment:

Device: Sham stimulation