Perioperative Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection (TMS-SLEEP-VATS)

August 31, 2026 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an investigator-initiated, single-center, prospective, randomized, double-blind, parallel-group, sham-controlled trial in adults undergoing elective thoracoscopic lung resection for primary lung cancer. Eligible participants will have evidence of preoperative sleep impairment, defined as an Insomnia Severity Index (ISI) score of at least 8 or a Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 on the most recent evaluable preoperative inpatient night.

Participants will be randomized in a 1:1 ratio to active or sham stimulation. Active treatment will consist of 1-Hz repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex at the F3 position, delivered at 100% of the resting motor threshold with 1,800 pulses per session over approximately 30 minutes. Five sessions will be delivered within a 7-day perioperative window: on 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 delivered on the same calendar day, and study procedures will not delay surgery, necessary clinical care, or discharge.

The sham group will undergo matched stimulation using a dedicated sham coil or validated active/sham masking module. Target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures will be matched to active treatment, but the sham procedure will not provide the intended therapeutic cortical stimulation. Participants and outcome assessors will remain blinded to treatment allocation; stimulation operators cannot be blinded because of device-operation requirements but will not participate in recruitment, primary outcome assessment, data entry, or statistical analysis.

The primary outcome is the participant-level mean RCSQ total score across postoperative inpatient nights 1, 2, and 3. RCSQ scores range from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare active and sham groups using ANCOVA/linear regression adjusted for the preoperative baseline RCSQ score and prespecified randomization stratification factors.

Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, sleep efficiency and other device-derived sleep measures when reliably available, postoperative pain, opioid consumption, rescue analgesia, quality of recovery, chest-tube duration, length of hospital stay, postoperative complications, longer-term sleep symptoms and chronic postsurgical pain, psychological symptoms, health-related quality of life, safety, and feasibility. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in spectral power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Perioperative Low-Frequency rTMS
Participants assigned to this arm will receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex at the F3 position. Stimulation will be delivered at 1 Hz and 100% of the resting motor threshold, with 1,800 pulses per session over approximately 30 minutes. Five sessions will be delivered within a 7-day perioperative window: on preoperative day 2, preoperative day 1, 2-6 hours after extubation when clinically stable, postoperative day 1, and postoperative day 2. Participants will continue to receive standard perioperative care and standardized inpatient sleep-support measures.
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.
Sham Comparator: Sham Perioperative rTMS
Participants assigned to this arm will receive matched sham rTMS using a dedicated sham coil or validated active/sham masking module. The sham procedure will match active treatment in target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures, but will not produce the intended therapeutic cortical stimulation. Five sham sessions will be delivered according to the same perioperative schedule as the active group. Participants will receive the same standard perioperative care and inpatient sleep-support measures.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3
Time Frame: Mornings after postoperative inpatient nights 1, 2, and 3
The Richards-Campbell Sleep Questionnaire (RCSQ) total score is calculated as the mean of five visual analog items and ranges from 0 to 100, with higher scores indicating better sleep. The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after postoperative inpatient nights 1, 2, and 3. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the preoperative baseline RCSQ score.
Mornings after postoperative inpatient nights 1, 2, and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Total Sleep Time Measured by Lifesense HR6 Across Postoperative Inpatient Nights 1-3
Time Frame: Postoperative inpatient nights 1, 2, and 3
Total sleep time (TST), measured in minutes by the Lifesense HR6 wearable device, will be averaged across valid device nights corresponding to postoperative inpatient nights 1, 2, and 3. At least two valid device nights are required to calculate the participant-level mean TST.
Postoperative inpatient nights 1, 2, and 3
Generalized Anxiety Disorder-7 Score
Time Frame: Preoperative baseline; within 24-72 hours after the final stimulation session
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, with total scores ranging from 0 to 21 and higher scores indicating greater symptom severity.
Preoperative baseline; within 24-72 hours after the final stimulation session
Patient Health Questionnaire-9 Score
Time Frame: Preoperative baseline; within 24-72 hours after the final stimulation session;
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), with total scores ranging from 0 to 27 and higher scores indicating greater symptom severity.
Preoperative baseline; within 24-72 hours after the final stimulation session;
EORTC QLQ-C30 Global Health Status/Quality of Life Score
Time Frame: Preoperative baseline; within 24-72 hours after the final stimulation session;
Health-related quality of life will be assessed using the authorized Chinese Mandarin (China) version of the EORTC QLQ-C30. The prespecified outcome is the Global Health Status/Quality of Life score, ranging from 0 to 100, with higher scores indicating better overall health-related quality of life.
Preoperative baseline; within 24-72 hours after the final stimulation session;
Proportion of Participants Completing at Least 4 of 5 Stimulation Sessions
Time Frame: During the 7-day perioperative treatment window
Treatment-course completion will be defined as completion of at least 4 of the 5 planned active or sham stimulation sessions.
During the 7-day perioperative treatment window
Incidence of Adverse Events and Serious Adverse Events
Time Frame: From the first study-specific procedure through the final prespecified safety follow-up at postoperative Month 12
Adverse events and serious adverse events will be recorded, including headache, scalp discomfort, dizziness, auditory discomfort, syncope, seizure, altered consciousness, new focal neurological deficits, vital-sign abnormalities, and interruptions related to study procedures.
From the first study-specific procedure through the final prespecified safety follow-up at postoperative Month 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Prespecified EEG Frequency-Band Power
Time Frame: Baseline and 2-24 hours after stimulation session 10.
Change in prespecified 64-channel EEG frequency-band power from baseline to the post-treatment assessment will be evaluated using the predefined EEG analysis pipeline.
Baseline and 2-24 hours after stimulation session 10.
Change in Prespecified EEG Functional Connectivity
Time Frame: Baseline and 2-24 hours after stimulation session 10.
Change in prespecified functional connectivity derived from 64-channel EEG recordings from baseline to the post-treatment assessment will be evaluated using the predefined connectivity analysis pipeline.
Baseline and 2-24 hours after stimulation session 10.
Change in TMS-Evoked Cortical Response
Time Frame: Baseline and 2-24 hours after stimulation session 10.
Change in the prespecified TMS-evoked cortical response measured by TMS-EEG from baseline to the post-treatment assessment will be evaluated.
Baseline and 2-24 hours after stimulation session 10.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMS-SLEEP-VATS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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