An interventional study of continuous Theta-burst stimulation and Sham in Postoperative Delirium, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
Postoperative delirium is common in elderly surgical patients and is associated with complications and prolonged hospitalisation. The aim of the RECOVER study is to assess the efficacy of electroencephalo graph (EEG)-transcranial magnetic stimulation (TMS) treatment for the management of postoperative delirium.
Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS), a pattern of TMS, was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network.This project team conducted a pilot study in the early stage and innovatively applied cTBS to treat postoperative delirium in elderly patients. The results preliminarily elucidate the safety, and feasibility of TMS in treating postoperative delirium in elderly patients.
In order to confirm the effectiveness of EEG-TMS therapy for POD and observe its impact on long-term prognosis, this project will conduct a prospective randomized controlled study to compare TMS therapy with sham stimulation therapy. The study will observe The duration of postoperative delirium during the 7-day intervention period, as well as severity of delirium, the time to successful discharge (defined as the patient surviving outside the hospital for at least 48 hours after discharge), and the 30-day and 90-day survival times, the number of patients receiving salvage drug treatment, and the number of days each patient received salvage drug treatment, the sensitivity, specificity, and predictive value of EEG. The trial will provide new ideas for the prediction and treatment of postoperative delirium in clinic.
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This study's planned enrollment of 98 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
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The TMS group uses effective coils for transcranial magnetic stimulation treatment twice a day, with a treatment mode of continuous theta burst stimulation (cTBS). The stimulation intensity is set at 80% of the minimum exercise threshold.
Device: continuous Theta-burst stimulation
For patients who experience postoperative delirium and are randomly assigned to the sham group, false coil stimulation is used. The auditory and scalp sensations induced by false coil stimulation are similar to those induced by effective coil stimulation, but there is no electromagnetic penetration into the brain or neural activation.
Device: Sham
Treatment parameters: each cTBS session consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 s, totaling 600 pulses, and every set simulation includes 3 sessions. Electrodes are attached to designated head regions (right dorsolateral prefrontal cortex).
the treatment mode was with sham coil.
Duration of postoperative delirium
Trained clinicians (who have received standardized CAM-ICU/3D-CAM training) will assess patients for POD using either the CAM-ICU or 3D-CAM tool twice a day.
Time frame: 7 days
Severity of delirium
The severity of delirium is measured using the The Delirium Rating Scale-Revised-98 (DRS-R-98), which has a total score range of 0 to 46, with higher scores indicating greater severity of delirium.
Time frame: 7 days
Time to successful hospital discharge
Defined as discharge from the hospital with survival outside the hospital for ≥48 hours
Time frame: 90 days
Survival at 30 and 90 days
All-cause mortality
Time frame: 90 days
Number of patients receiving rescue medications
e.g., sedatives, antipsychotics, or other adjunctive therapies for delirium/agitation
Time frame: 7 days
Total days of rescue medication use per patient
Calculated as the sum of days each patient received such therapies
Time frame: 7 days
Change from baseline on EEG
64-channel high-density EEG is used to assess the change of delta, theta, alpha, beta, gamma brainwave activity.
Time frame: baseline, 7 days
Change from baseline on sleep scales
The change is measured using the Pittsburgh Sleep Quality Index (PSQI), which provides a total score ranging from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, 90days
Change from baseline on stress scales
Stress is assessed using the Stress Appraisal Measure (SAM), which comprises six subscales rated on a 5-point Likert scale (1='not at all' to 5='extremely'). Higher scores on threat, centrality, and uncontrollability subscales indicate greater perceived stress, whereas higher scores on challenge, controllable-by-self, and controllable-by-others reflect lower stress.
Time frame: Baseline, 90days
Change from baseline on anxiety scales
Anxiety is assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, a 7-item self-report questionnaire where respondents rate symptom frequency over the past two weeks on a 4-point Likert scale (0="Not at all" to 3="Nearly every day"). The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.
Time frame: Baseline, 90days
Change from baseline on pain scales
The Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) assesses pain intensity across 22 items (0-10 scale), with higher scores indicating worse pain.
Time frame: Baseline, 90days
Change from baseline on depression scales
The Patient Health Questionnaire-9 (PHQ-9) assesses depression severity through 9 items scored 0-3, with total scores ranging 0-27 (higher scores = worse symptoms).
Time frame: Baseline, 90days
Change from baseline on cognition scales
Cognition is assessed using the Montreal Cognitive Assessment (MoCA), a 30-point screening tool evaluating multiple domains (attention, memory, language, visuospatial skills), with higher scores indicating better cognitive function
Time frame: Baseline, 90days
Plan to share: Undecided
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RenJi Hospital