Clinical trial NCT06482749: Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery
Official title: Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Patients
Cognitive Impairment
Repetitive Transcranial Magnetic Stimulation
Delayed Neurocognitive Recovery
Postoperative Neurocognitive Disorder
Keywords: Older patients
Cognitive impairment
Repetitive transcranial magnetic stimulation
Delayed neurocognitive recovery
Postoperative neurocognitive disorder
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Air Force Medicial University
name: Peking University Shenzhen Hospital
First posted: 2024-07-01
Enrollment: 568
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Incidence of delayed neurocognitive recovery
timeFrame: On the 5th day after surgery
Secondary outcomes:
measure: Incidence of delirium
timeFrame: Within 5 days after surgery
measure: Incidence of postoperative neurocognitive disorder at 30 days after surgery
timeFrame: On the 30(±3)th day after surgery
measure: Incidence of postoperative neurocognitive disorder at 180 days after surgery
timeFrame: On the 180(±15)th day after surgery
Other outcomes:
measure: Pain intensity within 5 days after surgery
timeFrame: Up to 5 days after surgery
measure: Length hospital stay after surgery
timeFrame: Up to 30 days after surgery
measure: Incidences of complications within 30 days after surgery
timeFrame: Up 30 days after surgery
measure: Quality of life at 30 days after surgery
timeFrame: On the 30(±3)th day after surgery
measure: Quality of life at 180 days after surgery
timeFrame: On the 180(±15)th day after surgery
measure: Event-free survival within 180 days after surgery
timeFrame: Up to 180 days after surgery
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangzhou
city: Xi'an
country: China
facility: Xijing Hospital, Air Force Medical University
state: Shannxi
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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