Repetitive transcranial magnetic stimulation to improve post-surgery thinking and memory in older adults
Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial
This trial will test whether repetitive transcranial magnetic stimulation (rTMS) given around the time of surgery helps older adults with mild-to-moderate cognitive impairment keep their thinking and memory after non-cardiac operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 568 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT06482749 on ClinicalTrials.gov |
What this trial studies
The trial enrolls patients aged 65 and older with preoperative mild-to-moderate cognitive impairment (MoCA >9 and <26) who are scheduled for elective non-cardiac surgery expected to last more than two hours and require at least a five-day hospital stay. Participants are randomized to receive perioperative rTMS targeted to the left dorsolateral prefrontal cortex or a sham stimulation control. Cognitive outcomes of interest include rates of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD) measured after surgery. The design compares active neural stimulation versus placebo-like sham to see if rTMS reduces early and later postoperative cognitive decline.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 65 or older with mild-to-moderate preoperative cognitive impairment (MoCA >9 and <26) scheduled for elective non-cardiac surgery lasting more than two hours and who can remain in hospital and attend follow-up at the study site.
Not a fit: Patients with more severe or very mild cognition outside the MoCA range, those undergoing neurosurgery, or individuals with contraindications to rTMS (for example epilepsy, pacemaker or other implanted metal/electrical devices, pregnancy, left-handedness, or severe sensory/language impairments) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of delayed cognitive recovery and longer-term postoperative cognitive problems in older patients with preexisting cognitive impairment.
How similar studies have performed: Prior trials and meta-analyses report cognitive benefits of rTMS in people with mild cognitive impairment and other cognitive disorders, but applying rTMS perioperatively to prevent DNR/POCD is relatively novel and less well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Guangzhou, China (Not_yet_recruiting)
- Xijing Hospital, Air Force Medical University — Xi'an, Shannxi, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: 8610 83572784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.