The Impact of Repetitive Transcranial Magnetic Stimulation on the Prognosis of Elderly Surgical Patients

NCT ID: NCT06392919

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2025-05-13

Brief Summary

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.

Detailed Description

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:

1. Elderly patients undergoing gastrointestinal surgery are enrolled primarily for the evaluation of POD, a short-term outcome assessed within 3 days postoperatively.

2. Elderly patients undergoing thoracic surgery are enrolled to evaluate POCD (at 1 month) and CPSP (at 3 months), which are longer-term outcomes.

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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction; Chronic Post-surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sham repetitive transcranial magnetic stimulation (rTMS group)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

repetitive transcranial magnetic stimulation (rTMS group)

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: 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.

Interventions

Repetitive Transcranial Magnetic Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 60 years;
• ASA ≤ 3;
• Elective surgery patients.

Exclusion Criteria

• Refusal to sign the consent form;
• Mini-Mental State Examination (MMSE) score < 15;
• Preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders;
• Preoperative cranial or scalp injuries;
• History of drug or alcohol abuse; Visual or auditory impairments, communication difficulties; Presence of metallic implants in the body; Preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Chaochao Zhong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao-Chao Zhong

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2024-K005-01

Identifier Type: -

Identifier Source: org_study_id