Clinical trial · Interventional
Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sleep Wake Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Low-Frequency Repetitive Transcranial Magnetic Stimulation | Device | — | UNRESOLVED |
| Matched Sham Repetitive Transcranial Magnetic Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Low-Frequency rTMS
- description
- Participants will receive five active low-frequency rTMS sessions during seven perioperative calendar days in addition to standard perioperative care.
- interventionNames
- Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
- type
- SHAM_COMPARATOR
- label
- Matched Sham rTMS
- description
- Participants will receive five matched sham sessions during the same perioperative schedule in addition to standard perioperative care.
- interventionNames
- Device: Matched Sham Repetitive Transcranial Magnetic Stimulation
Primary outcomes (1)
- measure
- Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available