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Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.
Patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants.Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rTMS group) and the intervention group (rTMS group, with rTMS intervention applied in the PACU after surgery) in a double-blind manner (with rTMS intervention and postoperative follow-up conducted by different researchers).
Note: This trial includes three co-primary outcomes-postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and chronic postoperative pain (CPSP). To account for the different nature and timelines of these outcomes, the study was designed to include two parallel patient cohorts under a unified protocol:
These two patient cohorts are studied concurrently but analyzed separately according to outcome-specific follow-up timelines and sample size estimations. A total of 122 gastrointestinal surgery patients were enrolled and analyzed for POD. The maximum estimated sample size is for the POCD and CPSP cohort (n=230). Results will be reported in phases corresponding to the completion of each outcome assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham repetitive transcranial magnetic stimulation (rTMS group) | No Intervention | After the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The Sham rTMS intervention occurs after the tracheal tube is removed in the PACU.In the sham rTMS group, the setup, including the stimulation site and parameters, is identical to that of the rTMS group. However, although the rTMS device is connected to the patient, no actual stimulation is delivered. | |
| repetitive transcranial magnetic stimulation (rTMS group) | Experimental | After the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The rTMS intervention occurs after the tracheal tube is removed in the PACU. The stimulation site is the DLPFC (left dorsolateral prefrontal cortex); the stimulation intensity is 100% of the Resting Motor Threshold (RMT); the frequency is 10 Hz; and the total number of pulses is 2000. The pulse characteristics include a duration of 5 seconds per session with a 25-second interval between sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | rTMS intervention timing: rTMS is applied after the tracheal tube is removed in the PACU. Stimulation site: DLPFC (left dorsolateral prefrontal cortex); Stimulation intensity: 100% RMT; Stimulation frequency: 10Hz; Total number of stimulation pulses: 2000. Pulse characteristics: Each duration lasts 5 seconds, with a 25-second interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium during the first 3 days after surgery | Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation during the first 3 days after surgery. | The first 3 days after surgery |
| Incidence of Postoperative Cognitive Dysfunction | Cognitive function assessed with MoCA (Montreal Cognitive Assessment) test on the 30th day after surgery | 1 month after surgery |
| Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery | CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection). Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement. | At 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chao-Chao Zhong | Affiliated Hospital of Nantong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Nantong University | Nantong | Jiangsu | 226001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41943114 | Derived | Zhou WW, Yang Z, Zhou C, Qiao Q, Zhang YH, Hu J, Gao YN, Chen LE, Yang WW, Qin YB, Zhong CC. Early repetitive transcranial magnetic stimulation for preventing chronic postoperative pain in older adults: a randomized clinical sub-study. BMC Med. 2026 Apr 6;24(1):316. doi: 10.1186/s12916-026-04845-5. |
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|
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D000079690 | Postoperative Cognitive Complications |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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