EEG-TMS for Postoperative Delirium After Cardiac Surgery

Sponsor
RenJi Hospital
Study ID
NCT07537725
Status
Not Yet Recruiting

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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Theta Burst Stimulation (TBS) — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Apr 17, 2026
Start date
Apr 27, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Theta Burst Stimulation (TBS)
    Participants receive active theta burst stimulation (TBS) delivered via a 12 cm coil. Each daily session consists of three cycles. One cycle includes intermittent TBS (iTBS) applied to the left dorsolateral prefrontal cortex (600 pulses, 3 repetitions, approximately 10 minutes), followed 30 minutes later by continuous TBS (cTBS) applied to the right dorsolateral prefrontal cortex (600 pulses, 3 repetitions, approximately 2 minutes). Stimulation intensity is set at 80% of the resting motor threshold. Cycles are separated by 15-minute intervals. The intervention is administered once daily for up to 5 days, with pauses if delirium resolves and resumption if delirium recurs.
  • Sham Comparator: Sham Stimulation
    Participants receive sham stimulation 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. The procedure, duration, frequency, and schedule are identical to the active TBS arm. The intervention is administered once daily for up to 5 days, with pauses and resumption following the same rules as the active arm.

Primary Outcome Measure

Duration of delirium [ Time Frame: Within the 5-day period following randomization, measured daily until delirium resolution or end of day 5 ]

Central Contacts

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