A Phase 2 interventional study of Active Low-Frequency Repetitive Transcranial Magnetic Stimulation and Sham Repetitive Transcranial Magnetic Stimulation in Carcinoma, Non-Small-Cell Lung and Sleep Wake Disorders, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 2, Interventional, and Treatment
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.
This is an investigator-initiated, single-center, prospective, randomized, double-blind, parallel-group, sham-controlled trial in adults with advanced non-small cell lung cancer (NSCLC) and in-hospital sleep disturbance. Eligible participants will have pathologically or cytologically confirmed unresectable stage IIIB-IIIC or stage IVA-IVB NSCLC, or recurrent disease after curative-intent treatment that is considered unsuitable for further curative local therapy. In-hospital sleep disturbance is defined as a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with a baseline Insomnia Severity Index (ISI) score of at least 8.
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. One session will be administered daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive their clinically indicated anticancer treatment and supportive care, and study procedures will not delay or interfere with necessary clinical treatment.
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. The stimulation operator cannot be blinded because of device-operation requirements but will not participate in participant recruitment, primary outcome assessment, data entry, or statistical analysis.
The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. RCSQ scores range from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare the active and sham groups using ANCOVA/linear regression adjusted for the mean RCSQ score from two consecutive valid baseline inpatient nights and prespecified randomization stratification factors.
Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, other device-derived sleep measures when reliably available, ISI, pain and opioid exposure, lung cancer-related symptom burden, fatigue, anxiety, depressive symptoms, health-related quality of life, functional status, length of hospital stay, anticancer-treatment interruption, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in frequency-band power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 160 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 18-80 years and able to understand the study and provide written .
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 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.
(ECOG) performance status 0-2 and estimated ≥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 , 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 , or brain metastases associated with cerebral edema, hemorrhage, focal neurological symptoms, or a need for escalating 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.
performance status ≥3, uncontrolled respiratory failure, delirium, or inability to reliably complete the prespecified sleep assessments.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
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.
Device: Sham 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. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days. No more than one study stimulation session will be administered on the same calendar day. Study stimulation will not be performed during intravenous anticancer drug infusion, blood transfusion, sedated bronchoscopy, or clinically significant infusion reactions.
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. Sham stimulation will be administered once daily for a total of 10 sessions completed within 10-14 days.
Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10
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 the nights following stimulation sessions 8, 9, and 10. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the mean RCSQ score from two consecutive valid baseline inpatient nights.
Time frame: Mornings after the nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
Mean Total Sleep Time Measured by Lifesense HR6 Across the Nights Following Stimulation Sessions 8-10
Total sleep time (TST), measured in minutes by the Lifesense HR6 wearable device, will be averaged across valid device nights corresponding to the nights following stimulation sessions 8, 9, and 10. At least two valid device nights are required to calculate the participant-level mean TST.
Time frame: Nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
Generalized Anxiety Disorder-7 Score
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.
Time frame: Baseline and within 24-72 hours after the final stimulation session
Patient Health Questionnaire-9 Score
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.
Time frame: Baseline; within 24-72 hours after the final stimulation session
EORTC QLQ-C30 Global Health Status/Quality of Life Score
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.
Time frame: Baseline; within 24-72 hours after the final stimulation session;
Proportion of Participants Completing at Least 8 of 10 Stimulation Sessions
Treatment-course completion will be defined as completion of at least 8 of the 10 planned active or sham stimulation sessions.
Time frame: During the 10-14-day treatment period
Incidence of Adverse Events and Serious Adverse Events
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.
Time frame: From the first study-specific procedure through the final prespecified safety follow-up at 12 weeks after hospital discharge
Change in Prespecified EEG Frequency-Band Power
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.
Time frame: Baseline and 2-24 hours after stimulation session 10.
Change in Prespecified EEG Functional Connectivity
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.
Time frame: Baseline and 2-24 hours after stimulation session 10.
Change in TMS-Evoked Cortical Response
Change in the prespecified TMS-evoked cortical response measured by TMS-EEG from baseline to the post-treatment assessment will be evaluated.
Time frame: Baseline and 2-24 hours after stimulation session 10.
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Jan 2028, 16 months later.
Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 16 months is below that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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