EEG-TMS Intervening Against Postoperative Delirium

Not Applicable

Not yet recruiting

• Conditions: Postoperative Delirium

• Registration Number: NCT07100197
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study Start: 2025-07-27
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-10-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Age ≥60 years;
2. Scheduled for non-cardiac surgery;
3. Positive assessment for delirium via the CAM-ICU or 3D-CAM after surgery.

Exclusion Criteria

1. Chronic use of antipsychotic medications;
2. Receipt of antipsychotic drugs prior to enrollment;
3. Permanently incapacitated patients (lacking decision-making capacity);
4. Inability to undergo delirium assessment (e.g., due to language barriers, deafness, blindness, aphasia, or coma);
5. Treatment withdrawal or brain death;
6. Known pregnancy or lactation;
7. Inability to obtain informed consent per national regulations;
8. Patients under compulsory hospitalization (involuntary commitment) by regulatory authorities;
9. Alcohol withdrawal delirium (delirium tremens);
10. Contraindications to transcranial magnetic stimulation (TMS);
11. Acute infectious diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of postoperative delirium	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Severity of delirium	7 days	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 to successful hospital discharge	90 days	Defined as discharge from the hospital with survival outside the hospital for ≥48 hours
Survival at 30 and 90 days	90 days	All-cause mortality
Number of patients receiving rescue medications	7 days	e.g., sedatives, antipsychotics, or other adjunctive therapies for delirium/agitation
Total days of rescue medication use per patient	7 days	Calculated as the sum of days each patient received such therapies

Trial Locations

Locations (1)

Renji hosipical, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China