EEG-TMS Intervening Against Postoperative Delirium

NCT ID: NCT07100197

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-27
• Study Completion Date: 2027-01-30

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TMS group

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.

Group Type: EXPERIMENTAL

continuous Theta-burst stimulation

Intervention Type: DEVICE

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).

SHAM group

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

the treatment mode was with sham coil.

Interventions

continuous Theta-burst stimulation

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).

Intervention Type: DEVICE

Sham

the treatment mode was with sham coil.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji hosipical, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Dan Huang, MD

Role: CONTACT

huangdan@renji.com

86-15921108822

Other Identifiers

RECOVER

Identifier Type: -

Identifier Source: org_study_id