NCT04661904

Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Delirium
• Transcranial Magnetic Stimulation, Repetitive

Interventions

Type	Name	Description
DEVICE	Continuous theta burst stimulation (cTBS)	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.
DEVICE	Sham stimulation	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.

Timeline

• Start date: 2021-07-07
• Primary completion: 2024-12-02
• Completion: 2024-12-13
• First posted: 2020-12-10
• Last updated: 2025-08-15

Locations

1 site across 1 country: China