EEG-TMS Intervening Against Postoperative Delirium

NCT07100197 | Not Yet Recruiting DMC

• 1 other identifier: RECOVER
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

cTBS; postoperative delirium; TMS; EEG

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative delirium

  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.

  7 days

Secondary Outcomes (5)

• Severity of delirium

  7 days

• Time to successful hospital discharge

  90 days

• Survival at 30 and 90 days

  90 days

• Number of patients receiving rescue medications

  7 days

• Total days of rescue medication use per patient

  7 days

Other Outcomes (7)

• Change from baseline on EEG

  baseline, 7 days

• Change from baseline on sleep scales

  Baseline, 90days

• Change from baseline on stress scales

  Baseline, 90days

Study Arms (2)

TMS group

EXPERIMENTAL

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.

Device: continuous Theta-burst stimulation

SHAM group

SHAM COMPARATOR

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.

Device: Sham

Interventions

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).

TMS group

Sham DEVICE

the treatment mode was with sham coil.

SHAM group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji hosipical, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Dan Huang, MD

CONTACT

86-15921108822; huangdan@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The effective coil or false coil shapes of the TMS group and the SHAM group were consistent. The assigned coils will blind clinical staff, patients, researchers, and outcome assessors who treat patients, and only data management personnel may unblind the assigned intervention measures. The statistical analysis of this experiment will be conducted using blinding, with the intervention group coded as (e.g. X and Y). Based on this blind analysis, two conclusions will be drawn: assuming X is the experimental group and Y is the control group, the other conclusion assumes the opposite. Two abstracts will be written and accepted by the author team. Afterwards, the blindness will be lifted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 3, 2025
• Study Start: July 27, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (1)