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EEG-TMS for Postoperative Delirium After Cardiac Surgery
Sponsor: RenJi Hospital
Summary
This is a prospective, single-center, randomized, double-blind, sham-controlled trial evaluating the safety and efficacy of transcranial magnetic stimulation (TMS) for the treatment of postoperative delirium in patients undergoing cardiac surgery with extracorporeal circulation. Eligible patients aged 50 years or older who develop delirium after surgery, as assessed by the CAM-ICU, will be randomized to receive either active TMS or sham stimulation. The intervention consists of three daily cycles of intermittent and continuous theta burst stimulation over five days. The primary outcome is the duration of delirium within the five-day intervention period. Secondary outcomes include delirium severity, time to successful discharge, and survival at 30 and 90 days. A total of 144 participants will be enrolled.
Official title: Transcranial Magnetic Stimulation for Postoperative Delirium After Cardiac Surgery: A Prospective, Single-Center, Randomized Double-Blind Controlled Study
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2026-04-27
Completion Date
2027-03-31
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
Theta Burst Stimulation (TBS)
A patterned form of transcranial magnetic stimulation delivered via a 12 cm coil. The active intervention consists of intermittent TBS (iTBS) applied to the left dorsolateral prefrontal cortex and continuous TBS (cTBS) applied to the right dorsolateral prefrontal cortex at 80% of resting motor threshold.
Sham Stimulation
Sham stimulation delivered using a coil identical in appearance to the active coil, which produces similar auditory and scalp sensations but delivers no electromagnetic penetration to the brain.