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NCT07796451

PHASE2

Perioperative Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

This randomized, double-blind, sham-controlled trial will evaluate whether perioperative low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve early postoperative in-hospital sleep quality in adults undergoing elective thoracoscopic lung resection for primary lung cancer. A total of 220 participants with preoperative sleep impairment will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex. Five stimulation sessions will be delivered within a 7-day perioperative window: two sessions before surgery, one session after extubation when the participant is clinically stable, and one session on each of postoperative days 1 and 2. The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the first three postoperative inpatient nights. The study will also evaluate wearable-device sleep measures, postoperative pain and analgesic use, recovery, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.

Official title: Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for Postoperative In-Hospital 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

2026-08-31

Completion Date

2028-09-01

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Sleep Wake Disorders Lung Neoplasms

Interventions

DEVICE

Active Low-Frequency Repetitive Transcranial Magnetic Stimulation

Active rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Five sessions will be delivered within a 7-day perioperative window: preoperative day 2, preoperative day 1, 2-6 hours after extubation when clinically stable, postoperative day 1, and postoperative day 2. No more than one study stimulation session will be administered on the same calendar day.

DEVICE

Sham Repetitive Transcranial Magnetic Stimulation

Sham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the study device. Target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Five sham sessions will be delivered according to the same perioperative schedule as the active treatment.

Inclusion Criteria: Age 18-80 years and able to understand the study and provide written informed consent. Primary lung cancer diagnosed or suspected based on pathology and/or thoracic surgical multidisciplinary assessment, with planned elective thoracoscopic lung resection. ASA physical status I-III, with expected awake extubation after surgery and ability to complete postoperative sleep and pain assessments. Preoperative sleep impairment, defined as an Insomnia Severity Index (ISI) score ≥8 or a Richards-Campbell Sleep Questionnaire (RCSQ) score \<70 on the most recent evaluable preoperative inpatient night. Able to complete TMS safety screening, resting motor threshold assessment, RCSQ/ISI assessments, at least one baseline night of Lifesense HR6 monitoring, and 64-channel EEG. The preoperative hospitalization schedule permits completion of two preoperative stimulation sessions, and postoperative hospitalization is expected to last at least three nights, allowing completion of the remaining three stimulation sessions without delaying surgery, necessary clinical care, or discharge. Exclusion Criteria: Unable to provide valid informed consent, unwilling to participate, or unable to reliably complete the primary RCSQ assessment. History of epilepsy or unexplained seizures, active intracranial hemorrhage, significant cerebral edema, elevated intracranial pressure, recent stroke, or severe traumatic brain injury. Intracranial ferromagnetic metal, cochlear implant, deep brain stimulator, cardiac pacemaker/implantable cardioverter-defibrillator, or other TMS-incompatible implant. Severe scalp infection, open wound, or inability to safely position the TMS coil or EEG cap. Pregnancy or any condition considered by the investigator to pose unacceptable risk. Emergency surgery, planned open thoracotomy, or planned prolonged postoperative mechanical ventilation or deep sedation. Chronic pain requiring regular preoperative opioid treatment, or pre-existing pain with an NRS score ≥3 in the target thoracic region. Persistent delirium, respiratory distress, hemodynamic instability, active bleeding, or need for urgent reoperation after extubation.

Clinical Research Directory

Perioperative Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

Summary

Key Details

Conditions

Interventions

Eligibility Criteria