Magnetic pulses to the brain may help cancer patients sleep better
NCT ID NCT07796438
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve sleep quality in adults with advanced non-small cell lung cancer who have trouble sleeping during hospital stays. Researchers will randomly assign 160 participants to receive either active rTMS or a sham (inactive) stimulation over 10 daily sessions. The main goal is to measure sleep quality using a questionnaire, with additional checks on sleep patterns, symptoms, quality of life, and brain activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex
- What this could lead to
- If it works, this could offer a drug-free way to improve sleep for people with advanced lung cancer, potentially easing a major source of distress during hospital stays.
- What could go wrong
- This is a phase 2 trial, so the treatment may not prove effective. The stimulation is non-invasive but can cause mild discomfort, headache, or rare seizure risk, and results may not generalize beyond this specific patient group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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