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EEG-TMS for Postoperative Delirium After Cardiac Surgery

ConditionDelirium
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 50 years or older;

undergoing cardiac surgery with cardiopulmonary bypass (coronary artery bypass grafting, aortic valve replacement, mitral valve surgery, or combined procedures);

positive assessment by CAM-ICU postoperatively.

Disqualifiers

Chronic antipsychotic treatment;

Receipt of antipsychotic medication before enrollment;

Patients with permanent loss of autonomy;

Not suitable for delirium assessment: including language disorder, deafness, blindness, aphasia, or coma;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Active Theta Burst Stimulation (TBS)Experimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of delirium

The total duration of delirium (in days) within the 5-day intervention period. Delirium is assessed twice daily (at least 6 hours apart) using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Duration is calculated as the number of days from the first positive CAM-ICU assessment to the last positive CAM-ICU assessment before delirium resolution, with partial days counted proportionally.

Time frame
Within the 5-day period following randomization, measured daily until delirium resolution or end of day 5

Secondary outcomes

1

Severity of Delirium

Delirium severity measured daily using the Delirium Rating Scale-Revised-98 (DRS-R-98) during the 5-day intervention period. Scores range from 0 to 39, with higher scores indicating more severe delirium.

Time frame
Daily during the 5-day intervention period
2

Length of hospital stay

Time from randomization to successful discharge, defined as discharge from the hospital followed by survival in the community for at least 48 hours.

Time frame
From randomization to date of successful discharge
3

Survival at 30 Days

Survival status at 30 days post-randomization.

Time frame
30 days after randomization
4

Survival at 90 Days

Survival status at 90 days post-randomization.

Time frame
90 days after randomization

Other outcomes

1

Incidence of Specific Adverse Events

Number of participants experiencing device-related adverse events, including seizure, vasovagal reflex, drowsiness, headache, facial discomfort, dental discomfort, and ocular or eyelid discomfort.

Time frame
From first stimulation session through 90 days after randomization

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

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