Older PatientsCognitive ImpairmentRepetitive Transcranial Magnetic StimulationDelayed Neurocognitive RecoveryPostoperative Neurocognitive Disorder
Investigational drug(s) / intervention(s)
Repetitive transcranial magnetic stimulationSham stimulation
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 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of delayed neurocognitive recovery — 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.
Trial sites (3)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
Peking University Shenzhen Hospital
Shenzhen
Guangzhou
Not Yet Recruiting
Xijing Hospital, Air Force Medical University
Xi'an
Shannxi
Not Yet Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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