Clinical trial · Interventional
Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC
Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Patients With Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Sham-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adults with advanced non-small cell lung cancer (NSCLC) and clinically significant in-hospital sleep disturbance. A total of 160 participants with unresectable stage IIIB-IIIC or stage IV NSCLC, or recurrent NSCLC not suitable for curative local treatment, 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 and will be delivered once daily for 10 sessions completed within 10-14 days. The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain and symptom burden, psychological symptoms, quality of life, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Sleep Wake Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Low-Frequency Repetitive Transcranial Magnetic Stimulation | Device | — | UNRESOLVED |
| Sham Repetitive Transcranial Magnetic Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Low-Frequency rTMS
- description
- 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, once daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures.
- interventionNames
- Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
- type
- SHAM_COMPARATOR
- label
- Sham rTMS
- description
- 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 the 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. Participants will receive the same clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures as the active rTMS group.
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 understand the study and provide written informed consent. Pathologically or cytologically confirmed non-small cell lung cancer (NSCLC), classified according to the IASLC 9th edition TNM system as unresectable stage IIIB-IIIC, stage IVA-IVB, or recurrent disease after curative-intent treatment and considered by a multidisciplinary team to be unsuitable for further curative local therapy. Receiving a stable first-line or later-line systemic anticancer treatment regimen, or receiving inpatient symptom/supportive care after anticancer treatment; the treatment plan must be established before randomization, with no planned initiation of new radiotherapy or change in systemic anticancer therapy before assessment of the primary outcome. Mean Richards-Campbell Sleep Questionnaire (RCSQ) score \<70 across two consecutive valid inpatient nights and baseline Insomnia Severity Index (ISI) score ≥8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥3 months. Hospitalized for anticancer treatment-related observation, symptom control, or supportive care, with an expected remaining hospital stay of at least 10 days from randomization and ability to complete 10 stimulation sessions and the primary outcome assessment within 14 days. Able to complete the prespecified RCSQ assessments and brief sleep diary, continuous Lifesense HR6 monitoring, and 64-channel EEG assessment. 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. Active or uncontrolled brain metastases, or brain metastases associated with cerebral edema, hemorrhage, focal neurological symptoms, or a need for escalating corticosteroid treatment. Untreated or unstable obstructive sleep apnea, or another primary sleep disorder requiring priority specialist management. Initiation, discontinuation, or ≥50% dose change of sedative-hypnotic medication within 48 hours before randomization, or a planned initiation/discontinuation of medication expected to substantially affect sleep before assessment of the primary outcome. Planned initiation of new whole-brain or local radiotherapy, first use of high-dose corticosteroids, or switching of systemic anticancer therapy before assessment of the primary outcome. ECOG performance status ≥3, uncontrolled respiratory failure, delirium, or inability to reliably complete the prespecified sleep assessments.
References
Publications (0)
Data not yet available