EEG-TMS Intervening Against Postoperative Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: continuous Theta-burst stimulation, Sham.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EEG-TMS Intervening Against Postoperative Delirium in Elderly Patients: A Randomized Clinical Trial
Overview
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.
Interventions
- Device 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). - Device Sham
the treatment mode was with sham coil.
Primary outcome measures
- Duration of postoperative delirium [Time frame: 7 days]
Secondary outcome measures (5)
- Severity of delirium [Time frame: 7 days]
- Time to successful hospital discharge [Time frame: 90 days]
- Survival at 30 and 90 days [Time frame: 90 days]
- Number of patients receiving rescue medications [Time frame: 7 days]
- Total days of rescue medication use per patient [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Age ≥60 years;
- Scheduled for non-cardiac surgery;
- Positive assessment for delirium via the CAM-ICU or 3D-CAM after surgery.
Exclusion criteria
- Chronic use of antipsychotic medications;
- Receipt of antipsychotic drugs prior to enrollment;
- Permanently incapacitated patients (lacking decision-making capacity);
- Inability to undergo delirium assessment (e.g., due to language barriers, deafness, blindness, aphasia, or coma);
- Treatment withdrawal or brain death;
- Known pregnancy or lactation;
- Inability to obtain informed consent per national regulations;
- Patients under compulsory hospitalization (involuntary commitment) by regulatory authorities;
- Alcohol withdrawal delirium (delirium tremens);
- Contraindications to transcranial magnetic stimulation (TMS);
- Acute infectious diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji hosipical, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07100197 · RECOVER