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

ConditionsCarcinoma, Non-Small-Cell Lung Sleep Wake Disorders

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
Device
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 Repetitive Transcranial Magnetic Stimulation
Device
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.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Active Low-Frequency rTMSExperimental treatment 1 intervention

Group B: Sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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;

Other outcomes

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.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

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