Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery

July 28, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial

Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mild cognitive impairment (MCI) affects 10-15% of the population over 65 years old. In patients for elective non-cardiac and emergency surgeries, the pooled prevalences of unrecognized cognitive impairment were 37.0% and 50.0%, respectively. Patients with preoperative cognitive impairment are at increased risk of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Therefore, perioperative neurocognitive protection is particularly important for patients with preoperative cognitive impairment.

Repetitive transcranial magnetic stimulation (rTMS) is a neural modulation technique. By acting on the brain and altering the membrane potential of cortical neurons, the generated pulsed magnetic fields affect neural metabolism and electrical activity and trigger a series of physiological and biochemical reactions. It was found that high frequency (>5 Hz) rTMS increases cortical excitability, whereas low frequency (<1Hz) rTMS reduces corticol excitability. The mechanism by which rTMS regulates brain function is generally believed to be related to the long-term enhancement and long-term inhibition of synaptic transmission function.

The left dorsolateral prefrontal cortex (DLPFC) is an important target of rTMS intervention for improving cognitive function. A meta-analysis showed that high-frequency rTMS on the DLPFC and low-frequency rTMS on the right medial prefrontal cortex improved memory function; high frequency rTMS on the right inferior frontal gyrus enhanced executive ability in non-surgical patients with mild cognitive impairment or Alzheimer's disease. Another meta-analysis showed that high-frequency rTMS on DLPFC is an effective therapeutic option for improving cognitive function in Alzheimer patients.

This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.

Study Type

Interventional

Enrollment (Estimated)

568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Principal Investigator:
          • Dong-Xin Wang, MD, PhD
        • Contact:
        • Contact:
    • Guangzhou
      • Shenzhen, Guangzhou, China, 516473
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Principal Investigator:
          • Tao Luo, MD
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Not yet recruiting
        • Xijing Hospital, Air Force Medical University
        • Contact:
        • Sub-Investigator:
          • Zhi-Hong Lu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥65 years;
  2. Patients with preoperative mild to moderate cognitive impairment, defined as 9<Montreal Cognitive Assessment (MoCA)<26;
  3. Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of >2 hours;
  4. Expected to stay in hospital for at least 5 days after surgery.

Exclusion Criteria:

  1. Left-handed;
  2. Primary school education level or below;
  3. Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;
  4. Neurosurgery;
  5. Presence of contraindications to rTMS treatment, including epilepsy, pregnant or lactating women, or with a metal or electric implanted device (e.g., deep brain stimulator, ventriculoperitoneal shunt, aneurysm clip, pacemaker, cochlear implant, or surgical staples on the scalp);
  6. Other situations that are deemed unsuitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Transcranial Magnetic Stimulation Group
Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily [10-12 am and 6-8 pm], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Device: Repetitive transcranial magnetic stimulation
Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily [10-12 am and 6-8 pm], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Sham Comparator: Sham Stimulation Group
Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily [10-12 am and 6-8 pm], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Device: Sham stimulation
Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily [10-12 am and 6-8 pm], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delayed neurocognitive recovery
Time Frame: On the 5th day after surgery
Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher score indicating better function) before surgery and at 5 days after surgery. A MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of delayed neurocognitive recovery.
On the 5th day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium
Time Frame: Within 5 days after surgery
Delirium is assessed with the 3D-Confusion Assessment Method (for non-intubated patients) or Confusion Assessment Method for the Intensive Care Unit (for intubated patients) twice daily (8-10 am and 4-6 pm).
Within 5 days after surgery
Incidence of postoperative neurocognitive disorder at 30 days after surgery
Time Frame: On the 30(±3)th day after surgery
Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 30±3 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.
On the 30(±3)th day after surgery
Incidence of postoperative neurocognitive disorder at 180 days after surgery
Time Frame: On the 180(±15)th day after surgery
Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 180±15 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.
On the 180(±15)th day after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length hospital stay after surgery
Time Frame: Up to 30 days after surgery
Length hospital stay after surgery.
Up to 30 days after surgery
Incidences of complications within 30 days after surgery
Time Frame: Up 30 days after surgery
Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
Up 30 days after surgery
Event-free survival within 180 days after surgery
Time Frame: Up to 180 days after surgery
Time interval from index surgery to cancer recurrence/metastasis/progression, new-onset cancer, new-onset serious illness (requiring hospitalization), or all-cause death, whichever comes first.
Up to 180 days after surgery
Pain intensity within 5 days after surgery
Time Frame: Up to 5 days after surgery
Pain intnsity is assessed with the Numerical Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) twice daily (8-10 am and 4-6 pm) during the first 5 days after surgery.
Up to 5 days after surgery
Quality of life at 30 days after surgery
Time Frame: On the 30(±3)th day after surgery
Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
On the 30(±3)th day after surgery
Quality of life at 180 days after surgery
Time Frame: On the 180(±15)th day after surgery
Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
On the 180(±15)th day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University Shenzhen Hospital
The First Affiliated Hospital of Air Force Medicial University

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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