EEG-TMS Intervening Against Postoperative Delirium (RECOVER)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Postoperative Delirium

Treatments: Device: Sham; Device: continuous Theta-burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07100197

RECOVER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups

TMS group

Experimental group

Description:

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.

Treatment:

Device: continuous Theta-burst stimulation

SHAM group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham