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NCT Number: NCT07100197

EEG-TMS Intervening Against Postoperative Delirium

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji hosipical, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Theta-burst Stimulation

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

Device

the treatment mode was with sham coil.

Primary outcomes

  1. Duration of postoperative delirium

    Time frame: 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 outcomes

  1. Severity of delirium

    Time frame: 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.

  2. Time to successful hospital discharge

    Time frame: 90 days

    Defined as discharge from the hospital with survival outside the hospital for ≥48 hours

  3. Survival at 30 and 90 days

    Time frame: 90 days

    All-cause mortality

  4. Number of patients receiving rescue medications

    Time frame: 7 days

    e.g., sedatives, antipsychotics, or other adjunctive therapies for delirium/agitation

  5. Total days of rescue medication use per patient

    Time frame: 7 days

    Calculated as the sum of days each patient received such therapies

Other outcomes

  1. Change from baseline on EEG

    Time frame: baseline, 7 days

    64-channel high-density EEG is used to assess the change of delta, theta, alpha, beta, gamma brainwave activity.

  2. Change from baseline on sleep scales

    Time frame: Baseline, 90days

    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.

  3. Change from baseline on stress scales

    Time frame: Baseline, 90days

    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.

  4. Change from baseline on anxiety scales

    Time frame: Baseline, 90days

    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.

  5. Change from baseline on pain scales

    Time frame: Baseline, 90days

    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.

  6. Change from baseline on depression scales

    Time frame: Baseline, 90days

    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).

  7. Change from baseline on cognition scales

    Time frame: Baseline, 90days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Huang, MD

CONTACT

[email protected]

86-15921108822

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

EEG-TMS Intervening Against Postoperative Delirium in Elderly Patients: A Randomized Clinical Trial

Acronym: RECOVER

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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