Clinical trial NCT04661904: Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
Official title: Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Transcranial Magnetic Stimulation, Repetitive
Keywords: postoperative delirium
continuous theta burst stimulation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2020-12-10
Enrollment: 324
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 of postoperative delirium as a preventive strategy.

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 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 3 days after surgery
measure: Cognitive function related to delirium
timeFrame: 3 days after surgery
measure: Severity of postoperative delirium
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Pain level
timeFrame: 3 days after surgery
measure: Sleep quality
timeFrame: 3 days after surgery
measure: Ability of daily living
timeFrame: up to 7 days after anesthesia/surgery
measure: Rate of complication and mortality
timeFrame: up to 7 days after anesthesia/surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai, Shanghai, China, 200072
name: Yuan Shen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.