Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery
NCT Number: NCT06482749
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Older Patients|Cognitive Impairment|Repetitive Transcranial Magnetic Stimulation|Delayed Neurocognitive Recovery|Postoperative Neurocognitive Disorder
Interventions: DEVICE: Repetitive transcranial magnetic stimulation|DEVICE: Sham stimulation
Sponsor: Peking University First Hospital
Collaborators: Xijing Hospital, Air Force Medical University|Peking University Shenzhen Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 568
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2029-12
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China|Peking University Shenzhen Hospital, Shenzhen, Guangzhou, 516473, China|Xijing Hospital, Air Force Medical University, Xi'an, Shannxi, 710032, China

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.

Primary Outcome Measures: 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., At 5 days after surgery
Secondary Outcome Measures: 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 6-8 pm)., Within 5 days after surgery|Incidence of 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 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of neurocognitive disorder., At 30 days after surgery|Incidence of 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 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of neurocognitive disorder., At 180 days after surgery
Other Outcome Measures: 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 (8:00-10:00 and 18:00-20:00) during the first 5 days after surgery., Up to 5 days after surgery|Length hospital stay after surgery, Length hospital stay after surgery., 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., 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., At 30 days 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., At 180 days 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., Up to 180 days after surgery