MedTrace Logo

EEG-TMS for Postoperative Delirium After Cardiac Surgery

NCT07537725 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • Delirium

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Dan Huang, MD · RenJi Hospital

  • Shujing Lin · RenJi Hospital

  • Tong Wu · RenJi Hospital

  • Xi Chen, MD · RenJi Hospital

  • Nan Wang · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2026-12-30
Completion
2027-03-31

More Related Trials

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 NCT07537725 on ClinicalTrials.gov