Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

NCT07796451 | Not Yet Recruiting

• 1 other identifier: TMS-SLEEP-VATS-01
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sleep Wake Disorders; Lung Neoplasms

Keywords

Repetitive Transcranial Magnetic Stimulation; Postoperative Sleep Disturbance; Thoracoscopic Lung Resection; Perioperative Care; Dorsolateral Prefrontal Cortex

Outcome Measures

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.

  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 (7)

• Time From End of Surgery to Live Discharge From the Continuous Acute-Care Hospitalization

  From end of surgery until live discharge, in-hospital death, or 90 days after surgery, whichever occurs first.

• Mean Standardized Cough Pain Numeric Rating Scale Score Across the First 3 Postoperative Mornings

  Postoperative mornings 1-3.

• Change From Baseline in Quality of Life, Anxiety, and Depression at Postoperative Day 30

  Baseline and postoperative day 30 ± 7 days.

• Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score on Postoperative Day 3

  Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.

• Mean Actigraphy-Estimated Total Sleep Time Across Postoperative Inpatient Nights 1-3

  Postoperative inpatient nights 1-3.

Other Outcomes (2)

• Change From Baseline in Frontal Relative Beta Power on 64-Channel Electroencephalography

  Baseline before randomization and postoperative day 3, targeted at least 24 hours after the fifth stimulation session.

• Incidence of Adverse Events and Serious Adverse Events

  From the first study stimulation through 30 days after the last stimulation session.

Study Arms (2)

Active Low-Frequency rTMS

EXPERIMENTAL

Participants will receive five active low-frequency rTMS sessions during seven perioperative calendar days in addition to standard perioperative care.

Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation

Matched Sham rTMS

SHAM COMPARATOR

Participants will receive five matched sham sessions during the same perioperative schedule in addition to standard perioperative care.

Device: Matched Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Matched Sham Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Matched Sham rTMS

Active Low-Frequency Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Active Low-Frequency rTMS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Sleep Wake Disorders; Lung Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will remain blinded to treatment assignment. Follow-up staff and statisticians will also be blinded whenever feasible. The rTMS operator cannot be blinded because the operator must deliver the assigned device program; the operator will not participate in recruitment, outcome assessment, database cleaning, or statistical analysis. Active and sham sessions will use matched procedures, positioning, sound, duration, and staff interaction. Emergency unblinding will occur only when knowledge of assignment is necessary for participant safety and will be documented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: September 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09