An interventional study of Repetitive transcranial magnetic stimulation and Sham stimulation in Older Patients, Cognitive Impairment and Repetitive Transcranial Magnetic Stimulation, sponsored by Peking University First Hospital. Recruiting at 3 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 568 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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Exclusion Criteria:
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
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
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 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.
Incidence of delayed neurocognitive recovery
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.
Time frame: On the 5th day after surgery
Incidence of delirium
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).
Time frame: Within 5 days after surgery
Incidence of postoperative neurocognitive disorder at 30 days 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.
Time frame: On the 30(±3)th day after surgery
Incidence of postoperative neurocognitive disorder at 180 days 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.
Time frame: On the 180(±15)th day after surgery
Pain intensity within 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.
Time frame: Up to 5 days after surgery
Length hospital stay after surgery
Length hospital stay after surgery.
Time frame: Up to 30 days after surgery
Incidences of complications within 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.
Time frame: Up 30 days after surgery
Quality of life at 30 days 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.
Time frame: On the 30(±3)th day after surgery
Quality of life at 180 days 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.
Time frame: On the 180(±15)th day after surgery
Event-free survival within 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.
Time frame: Up to 180 days after surgery
Plan to share: No
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Peking University First Hospital