State of the science on mild cognitive impairment (MCI).
Nicole D Anderson
https://pubmed.ncbi.nlm.nih.gov/30651152Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
ID06482749
Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial
Led by Peking University First Hospital · Updated on 2025-07-31
568
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
T
The First Affiliated Hospital of Air Force Medicial University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) compared to a sham intervention on postoperative neurocognitive function in older patients with preoperative cognitive impairment. Patients with mild cognitive impairment (MCI) aged 65 years or older, especially those undergoing elective non-cardiac surgery, face increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). The study explores rTMS as a potential neurocognitive protective method in this vulnerable population. Participants will be randomly assigned to receive either real or sham rTMS applied to the left dorsolateral prefrontal cortex (DLPFC). The treatment involves twice-daily sessions for 5 days—starting one day before surgery and continuing for four consecutive days after surgery, with no treatment on the surgery day itself. Each session uses an "8" shaped coil at 10 Hz frequency, with 2000 pulses over 20 minutes. During the study, patients will be monitored for neurocognitive function outcomes including the incidence of delayed neurocognitive recovery on day 5 after surgery, delirium within 5 days, and postoperative neurocognitive disorder at 30 and 180 days post-surgery. Assessments include cognitive tests and clinical evaluations, with the study duration covering preoperative through long-term postoperative follow-up to capture neurocognitive changes and recovery patterns.
CONDITIONS
Brief Title
Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 65 years or older
- Mild to moderate preoperative cognitive impairment with Montreal Cognitive Assessment (MoCA) score between 10 and 25
- Scheduled for elective non-cardiac surgery under general anesthesia lasting more than 2 hours
- Expected hospital stay of at least 5 days after surgery
You will not qualify if you...
- Left-handed
- Education level of primary school or below
- Mental illness, intellectual disability, auditory or visual dysfunction, language impairment, severe neurological disorders, or other diseases preventing evaluation
- Neurosurgery
- Contraindications to rTMS such as epilepsy, pregnancy, lactation, or implanted metal/electric devices (e.g., deep brain stimulator, pacemaker)
- Any other conditions deemed unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
Duration - 5 days
Participants receive repetitive transcranial magnetic stimulation (rTMS) or sham stimulation over the left dorsolateral prefrontal cortex twice daily for 5 days (1 day before surgery and 4 days after surgery). There is no intervention on the day of surgery.
Twice daily visits for 5 days (excluding the surgery day)
Post-operative Follow-up
Duration - Up to 6 months
Participants are assessed for neurocognitive recovery and potential postoperative cognitive disorders.
Visits on Day 5, Day 30 (±3 days), and Day 180 (±15 days) after surgery
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University Shenzhen Hospital
Shenzhen, Guangzhou, China, 516473
Not Yet Recruiting
3
Xijing Hospital, Air Force Medical University
Xi'an, Shannxi, China, 710032
Not Yet Recruiting
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Research Team
D
Dong-Xin Wang, MD, PhD
H
Hao Kong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23194830Similar clinical improvement and maintenance after rTMS at 5 Hz using a simple vs. complex protocol in Alzheimer's disease.
R Alcalá-Lozano, E Morelos-Santana, J F Cortés-Sotres...
https://pubmed.ncbi.nlm.nih.gov/29326021