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NCT07796451

Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

This single-center randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) improves postoperative inpatient sleep in adults undergoing elective thoracoscopic lung resection for primary lung cancer. A total of 220 participants will be assigned 1:1 to active or matched sham stimulation. Five sessions will be delivered during seven perioperative calendar days, with no more than one session per day. The primary outcome is each participant's mean Richards-Campbell Sleep Questionnaire (RCSQ) total score across postoperative inpatient nights 1-3, calculated from at least two eligible nights. Secondary outcomes include length of postoperative hospitalization, pain, quality of life, actigraphy-derived sleep, anxiety, depression, electroencephalographic measures, and safety.

Official title: Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for Postoperative Inpatient Sleep Disturbance in Patients Undergoing Thoracoscopic Lung Resection: A Randomized, Double-Blind, Sham-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2026-10-01

Completion Date

2028-10-01

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Sleep Wake Disorders Lung Neoplasms

Interventions

DEVICE

Active Low-Frequency Repetitive Transcranial Magnetic Stimulation

Stimulation will target the left dorsolateral prefrontal cortex at F3 with a figure-of-eight coil. Each session will use 1 Hz stimulation at 100% of resting motor threshold, 1,800 pulses, and a duration of approximately 30 minutes. Sessions are planned for preoperative day -2, preoperative day -1, 2-6 hours after awake extubation when clinically stable, postoperative day 1, and postoperative day 2. A maximum of one session is allowed per calendar day.

DEVICE

Matched Sham Repetitive Transcranial Magnetic Stimulation

A dedicated compatible sham coil or coded active/sham module will be used. Target, participant posture, coil placement procedure, acoustic cues, session duration, staff interaction, and visit schedule will match the active arm, but no intentional cortical stimulation will be delivered. The standard active coil rotated 90 degrees will not be used as the sham method. A maximum of one session is allowed per calendar day.

Inclusion Criteria: * Age 18-80 years and able to provide written informed consent. * Primary lung cancer confirmed by pathology or multidisciplinary evaluation and scheduled for elective thoracoscopic lung resection, including wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy. * American Society of Anesthesiologists physical status I-III, with awake extubation and reliable self-report expected after surgery. * Protocol-defined sleep impairment: Insomnia Severity Index score ≥8 or the most recent evaluable preoperative inpatient RCSQ total score \<70. * Baseline TMS safety screening, resting motor threshold, RCSQ, ISI, HR6 actigraphy, and 64-channel EEG can be completed before randomization and the first study stimulation. * The clinical schedule permits two preoperative and three postoperative sessions and at least three postoperative inpatient nights without delaying necessary clinical care or discharge. Exclusion Criteria: * History of epilepsy or seizure; intracranial hemorrhage, cerebral edema, increased intracranial pressure, recent stroke, or recent traumatic brain injury judged to increase TMS risk. * Ferromagnetic or electronic implants incompatible with TMS, including incompatible intracranial metal, cochlear implant, deep-brain stimulator, or other implanted electronic device near the stimulation field. * Severe scalp infection, open wound, or other local condition preventing safe coil placement. * Pregnancy or another condition judged by the investigator to create unacceptable risk from study procedures. * Emergency surgery, planned open thoracotomy, planned prolonged postoperative mechanical ventilation or deep sedation, or another perioperative plan that makes the stimulation and assessment schedule infeasible. * Regular opioid treatment for chronic pain or baseline chest-wall pain numeric rating scale score ≥3. * Unstable consciousness, respiratory status, circulation, or another acute condition that prevents reliable self-report or safe study procedures.

Clinical Research Directory

Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

Summary

Key Details

Conditions

Interventions

Eligibility Criteria