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

NCT06392919 | Completed

• 1 other identifier: 2024-K005-01
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

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.

repetitive transcranial magnetic stimulation (rTMS group)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Pain, Postoperative

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders; Pain

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Chao-Chao Zhong

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: May 3, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)