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
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
Treatments tested in this trial
- Theta Burst Stimulation (TBS)
- Sham Stimulation
Treatment groups
144 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov