EEG-TMS for Postoperative Delirium After Cardiac Surgery

NCT07537725 | Not Yet Recruiting DMC

• 1 other identifier: IIT-20250513
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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.

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

Secondary Outcomes (5)

• Severity of Delirium

  Daily during the 5-day intervention period

• Length of hospital stay

  From randomization to date of successful discharge

• Survival at 30 Days

  30 days after randomization

• Survival at 90 Days

  90 days after randomization

• Rescue Medication Use

  Within the 5-day intervention period

Other Outcomes (1)

• Incidence of Specific Adverse Events

  From first stimulation session through 90 days after randomization

Study Arms (2)

Active Theta Burst Stimulation (TBS)

EXPERIMENTAL

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.

Device: Theta Burst Stimulation (TBS)

Sham Stimulation

SHAM COMPARATOR

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.

Device: Sham Stimulation

Interventions

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.

Also known as: Sham TBS

Sham Stimulation

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.

Also known as: TBS, Puzhuo Magnetic Stimulator

Active Theta Burst Stimulation (TBS)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Withdrawal of treatment or brain death;
• Known pregnancy or breastfeeding;
• Unable to provide consent according to national regulations;
• Patients involuntarily hospitalized by regulatory authorities (compulsory measures);
• Alcohol-induced delirium / delirium tremens;
• Contraindications to transcranial magnetic stimulation, including intracranial or cervical metal implants, history of brain surgery, history of epilepsy, cardiac pacemaker or implantable cardioverter-defibrillator, cochlear implant, known intracranial space-occupying lesions, cardiac pacemaker implantation, recent stroke (\<3 months);
• Acute infectious diseases;
• Preoperative severe hemodynamic instability (e.g., requiring intra-aortic balloon pump or extracorporeal membrane oxygenation support).

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dan Huang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Shujing Lin

  RenJi Hospital

  STUDY DIRECTOR

• Tong Wu

  RenJi Hospital

  STUDY DIRECTOR

• Xi Chen, MD

  RenJi Hospital

  STUDY DIRECTOR

• Nan Wang

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Dan Huang, MD

CONTACT

+86 159 2110 8822; huangdan@renji.com

Shujing Lin

CONTACT

+86 155 5836 6370; linshujing@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 17, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share