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NOT YET RECRUITING
NCT07796438
PHASE2

Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-08-31

Completion Date

2028-09-01

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

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. 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.

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. Sham stimulation will be administered once daily for a total of 10 sessions completed within 10-14 days.