Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Guangzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
DeviceStimulation 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.
Matched Sham Repetitive Transcranial Magnetic Stimulation
DeviceA 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Active Low-Frequency rTMSExperimental treatment 1 intervention
Group B: Matched Sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3
The RCSQ contains five visual-analogue items scored from 0 to 100, with higher scores indicating better perceived sleep. A nightly total score is the mean of completed items and is eligible when at least 4 of 5 items are completed. For each participant, the outcome is the arithmetic mean of at least two eligible nightly total scores collected on postoperative inpatient nights 1-3; the mean may therefore use two or three nights. The primary model will adjust for the most recent evaluable pre-randomization inpatient RCSQ score, randomization strata, and regular hypnotic use.
Time frame
Postoperative inpatient nights 1-3; each questionnaire is completed the following morning, preferably 07:00-10:00 and no later than 12:00 if delayed by clinical care.Secondary outcomes
1
Time From End of Surgery to Live Discharge From the Continuous Acute-Care Hospitalization
Time in hours or days from the recorded end of surgery to live discharge from the same continuous acute-care hospitalization. Death before discharge will be handled as a competing event according to the statistical analysis plan.
Time frame
From end of surgery until live discharge, in-hospital death, or 90 days after surgery, whichever occurs first.2
Mean Standardized Cough Pain Numeric Rating Scale Score Across the First 3 Postoperative Mornings
Cough pain will be rated from 0 to 10, with higher scores indicating worse pain. The participant-level outcome will be the mean of at least two available standardized morning assessments during postoperative days 1-3.
Time frame
Postoperative mornings 1-3.3
Change From Baseline in Quality of Life, Anxiety, and Depression at Postoperative Day 30
Supportive follow-up will assess EORTC QLQ-C30 Global Health Status/Quality of Life, GAD-7, and PHQ-9 scores. Each change is follow-up minus baseline, with direction interpreted according to the corresponding scale.
Time frame
Baseline and postoperative day 30 ± 7 days.4
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score on Postoperative Day 3
The EORTC QLQ-C30 Global Health Status/Quality of Life domain is transformed to a 0-100 score, with higher scores indicating better global health and quality of life. Change is calculated as postoperative day 3 minus baseline; positive values indicate improvement.
Time frame
Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.Other outcomes
1
Change From Baseline in Frontal Relative Beta Power on 64-Channel Electroencephalography
Relative beta power will be calculated for frontal electrodes F3, Fz, and F4 as power in the 13-30 Hz band divided by power in the 1-40 Hz band. Change from baseline will be compared between treatment groups.
Time frame
Baseline before randomization and postoperative day 3, targeted at least 24 hours after the fifth stimulation session.2
Incidence of Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be collected and assessed for severity and relationship to study procedures, including headache, scalp discomfort, dizziness, syncope, mood change, and seizure.
Time frame
From the first study stimulation through 30 days after the last stimulation session.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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