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Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

NCT04661904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Postoperative Delirium
  • Transcranial Magnetic Stimulation, Repetitive

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Shanghai 10th People's Hospital

    lead OTHER

Principal Investigators

  • Yuan Shen, MD, PhD · Shanghai, Shanghai, China, 200072

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2024-12-02
Completion
2024-12-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661904 on ClinicalTrials.gov