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Clinical Trials in China / NCT07753473
Recruiting Not applicable

Modulatory Effects of Personalized Transcranial Magnetic Stimulation (TMS) on Heart-Brain Coupling in Individuals With Depressive Tendencies

NCT07753473 · tracked via the Priya Life Science China tracker
Sponsor
Xidian University
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-07

Condition(s) studied

Depression DisorderfMRI ResearchHeart-Brain Coupling

Investigational drug(s) / intervention(s)

DLPFC-insula TMSDLPFC-sgACC TMS10-20 F3 TMSsham TMS

DLPFC-insula TMS: Transcranial magnetic stimulation was applied to the dorsolateral prefrontal cortex (DLPFC); the specific insular subregion exerting the greatest negative influence on the left DLPFC was identified based on Granger causality connectivity. Stimulation parameters were as follows: frequency of 10 Hz, intensity of 90% of the resting motor threshold (RMT), a 2-second stimulation duration followed by an 8-second inter-stimulus interval, and 45 repeated sequences (each comprising 20 pulses) for a total of 900 pulses, resulting in a total session duration of approximately 7.5 minutes.

DLPFC-sgACC TMS: Transcranial magnetic stimulation was applied to the dorsolateral prefrontal cortex, with individualized targeting of the region in the left dorsolateral prefrontal cortex showing the strongest negative functional correlation with the subgenual anterior cingulate cortex. The stimulation parameters were: frequency of 10 Hz, intensity of 90% of the resting motor threshold (RMT), 2-second stimulation duration, and 8-second inter-stimulus interval; each sequence comprised 20 pulses, with 45 sequences repeated for a total of 900 pulses, resulting in a total session duration of approximately 7.5 minutes.

10-20 F3 TMS: Transcranial magnetic stimulation was applied to the dorsolateral prefrontal cortex, targeting the F3 site based on the international 10-20 system. The stimulation parameters were as follows: frequency of 10 Hz, intensity of 90% RMT, 2-second stimulation duration, 8-second inter-train interval, and 20 pulses per train; a total of 45 trains were delivered (900 pulses in total), with a single session lasting approximately 7.5 minutes.

sham TMS: A form of sham transcranial magnetic stimulation-either inactive or sensory-matched-designed to simulate the sensation of stimulation associated with device activation without delivering therapeutic frequencies.

Study summary

This study focuses on individuals with depressive tendencies and investigates the regulatory effects of Transcranial Magnetic Stimulation (TMS)-guided by personalized functional connectivity mapping-on heart-brain coupling in this population, while also exploring the underlying mechanisms.Participants will undergo 3T functional magnetic resonance imaging (fMRI) scans, followed by four different types of neurostimulation: stimulation targeting individualized Dorsolateral Prefrontal Cortex (DLPFC) -Subgenual Anterior Cingulate Cortex (sgACC) functional connectivity, stimulation targeting individualized DLPFC-insula functional connectivity, standard F3 targeting, and sham stimulation. The order of these stimulation sessions will be randomized. Researchers will simultaneously record the participants' electroencephalogram (EEG) and electrocardiography (ECG) signals before and after stimulation, and will record ECG in real-time during the stimulation. The primary objective of this study is to investigate the effects of DLPFC targeting specificity on metrics such as heart-brain coupling in individuals with depressive tendencies, thereby providing a basis for future research on objective assessment and personalized interventions for depression.

Eligibility

Sex
ALL
Min age
18 Years
Max age
30 Years
Healthy volunteers
Accepted
Inclusion Criteria: 一、Inclusion criteria for the depressed group: 1. Aged 18-30 years; 2. Recent feelings of low mood and presence of depressive symptoms; 3. Physically healthy, with no history of neurological disorders; 4. No participation in other neuromodulation experiments within the past month; 5. Normal hearing and normal (or corrected-to-normal) vision; 6. PHQ-9 score \> 5 and BDI-II score \> 13; 7. Avoidance of staying up late, alcohol consumption, and excessive caffeine intake prior to the experiment; 8. Able and willing to cooperate with the completion of scale assessments. 二、Inclusion criteria for healthy participants: (1) Aged 18-30 years; (2) No significant symptoms of depression and no history of neuropsychiatric disorders; (3) Physically healthy with no history of neurological disorders; (4) No participation in other neuromodulation experiments within the past month; (5) Normal hearing and normal (or corrected-to-normal) vision; (6) PHQ-9 score \< 5 and BDI-II score \< 13; (7) Avoidance of staying up late, alcohol consumption, and excessive caffeine intake prior to the experiment; (8) Able and willing to cooperate with the completion of scale assessments. Exclusion Criteria: 1. History of head trauma (including neurosurgery), stroke, elevated intracranial pressure, or other brain-related disorders; 2. History of epileptic seizures or family history of epilepsy; 3. Receipt of TMS or other neuromodulation stimulation within the past month; 4. Presence of intracranial or internal metallic foreign bodies, electrodes made of silver or gold, or metal prostheses; 5. Presence of devices potentially affected by TMS, such as pacemakers, drug pumps, cochlear implants, or implanted brain stimulators; 6. Severe or recent cardiac, pulmonary, or hematopoietic system disorders, or other neurological diseases; 7. Clinically diagnosed moderate-to-severe depressive disorder; 8. Substance abuse, alcohol dependence, etc.; 9. Current active suicidal ideation or suicidal behavior; Refusal to sign the informed consent form.

Primary outcome measure(s)

  • TMS-induced heart-brain coupling — Perioperative. During the 7-minute-22-second treatment period under each stimulation condition.
    By linking the stimulation rhythm to the inter-beat interval and quantifying the rhythmic effects of TMS, direct evidence is provided regarding the engagement of the prefrontal-vagal pathway.
  • Phase-amplitude coupling — Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.
    It reflects the real-time exchange of information between the central nervous system and the autonomic nervous system, serving as an important biomarker of the functional status of the "brain-heart axis."
  • Heartbeat-evoked potentials — Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.
    An EEG component extracted via time-locking to the cardiac R-peak. It precisely reflects the cerebral cortex's processing of cardiac afferent signals and interoceptive function.

Trial sites (1)

FacilityCityRegionStatus
Xidian University Xi'an Shaanxi Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753473 on ClinicalTrials.gov ↗ ← All trials in China