An interventional study of DLPFC-insula TMS and DLPFC-sgACC TMS in Depression Disorder, fMRI Research and Heart-Brain Coupling, sponsored by Xidian University. Recruiting at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Xidian University · Not applicable, Interventional, and Basic science
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.
This is an exploratory, randomized, single-blind, sham-controlled, within-subject crossover study designed to investigate the regulatory effects-and underlying mechanisms-of TMS (based on individualized functional connectivity targeting) on heart-brain coupling in individuals with depressive tendencies.
Participants will undergo structural and functional neuroimaging using a 3T MRI scanner. The imaging protocol includes a structural T1-weighted scan and a functional blood-oxygen-level-dependent (BOLD) scan, used for structural image registration and functional connectivity analysis to identify TMS stimulation targets.
In this study targeting individuals with depressive tendencies, each participant will undergo four distinct stimulation conditions: individualized DLPFC-sgACC functional connectivity targeting, individualized DLPFC-insula functional connectivity targeting, standard F3 targeting, and sham stimulation. The order of these four conditions will be balanced using a Latin square design to minimize sequence effects, learning effects, and carry-over effects between conditions; a minimum interval of 5 days will be maintained between experimental sessions. High-frequency Repetitive transcranial magnetic stimulation (rTMS) will be used for the intervention, with the following parameters: stimulation frequency of 10 Hz, intensity at 90% of resting motor threshold (RMT), 2-second stimulation duration, 8-second inter-train interval, 20 pulses per train, and 45 repetitions (totaling 900 pulses), resulting in a total session duration of approximately 7.5 minutes.
Primary measures include: Phase-Amplitude Coupling (PAC), which reflects real-time information exchange between the central and autonomic nervous systems and serves as a key biomarker for the functional status of the "brain-heart axis"; TMS-induced Heart-Brain Coupling (HBC), which quantifies the rhythmic effects of TMS and provides direct evidence regarding the engagement of the prefrontal-vagal pathway; Heartbeat-Evoked Potentials (HEP), an EEG component extracted via time-locking to the ECG R-peak, which precisely reflects cortical processing of cardiac afferent signals and interoceptive function; and Heart Rate Variability (HRV), which reflects the balance of sympathetic and parasympathetic regulation. Secondary measures include EEG power spectra, fMRI data, heart rate (HR), and clinical assessment scales.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Xidian University is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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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.
一、Inclusion criteria for the depressed group:
(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:
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.
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.
At this stage, participants will receive transcranial magnetic stimulation with a frequency of 10Hz and a stimulation intensity of 90% of the resting exercise threshold; Each stimulation lasts for 2 seconds, with a stimulation interval of 8 seconds; A total of 45 repeated stimuli were performed, each containing 20 pulses, for a total of 900 pulses. And the stimulation targets are located through a transcranial magnetic stimulation laser navigation system. The entire stimulation process lasts approximately 7.5 minutes.
Device: DLPFC-sgACC TMS
At this stage, participants will receive transcranial magnetic stimulation with a frequency of 10Hz and a stimulation intensity of 90% of the resting exercise threshold; Each stimulation lasts for 2 seconds, with a stimulation interval of 8 seconds; A total of 45 repeated stimuli were performed, each containing 20 pulses, for a total of 900 pulses. And the stimulation targets are located through a transcranial magnetic stimulation laser navigation system. The entire stimulation process lasts approximately 7.5 minutes.
Device: DLPFC-insula TMS
At this stage, participants will receive transcranial magnetic stimulation with a frequency of 10Hz and a stimulation intensity of 90% of the resting exercise threshold; Each stimulation lasts for 2 seconds, with a stimulation interval of 8 seconds; A total of 45 repeated stimuli were performed, each containing 20 pulses, for a total of 900 pulses. And the stimulation targets are located through 10-20 international standard lead EEG positioning caps. The entire stimulation process lasts approximately 7.5 minutes.
Device: 10-20 F3 TMS
At this stage, participants will receive transcranial magnetic stimulation with a frequency of 10Hz and a stimulation intensity of 90% of the resting exercise threshold; Each stimulation lasts for 2 seconds with an interval of 8 seconds. Using a transcranial magnetic stimulation laser navigation system to locate stimulation targets, rotate the stimulation coil 90 degrees to apply false stimulation. The entire stimulation process lasts approximately 7.5 minutes.
Device: sham 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.
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.
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.
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.
TMS-induced heart-brain coupling
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.
Time frame: Perioperative. During the 7-minute-22-second treatment period under each stimulation condition.
Phase-amplitude coupling
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."
Time frame: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.
Heartbeat-evoked potentials
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.
Time frame: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.
EEG power spectrum
It describes the distribution of power (energy) of EEG signals as a function of frequency. By transforming complex time-domain EEG signals into the frequency domain, it reveals energy distribution across different frequency bands, thereby helping to identify changes in the brain's functional state under various conditions.
Time frame: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.
Functional connectivity of brain networks
The analysis of functional connectivity in brain networks aims to reveal the mechanisms of coordinated activity among brain regions and dynamic individual differences, thereby providing an objective scientific basis for the diagnosis, elucidation of pathological mechanisms, and precision treatment of neuropsychiatric disorders.
Time frame: Baseline. During the 6-minute-30-second fMRI scan.
Transient Assessment Scale
Patient Health Questionnaire -9 items, with a total score range of 0-27 points. The higher the score, the more severe the depressive symptoms may be. The Beck Depression Inventory (BDI-II) has a total score range of 0-63, with higher scores indicating more severe depressive symptoms. The State Trait Anxiety Inventory (STAI) is a psychological assessment tool used to measure anxiety, divided into two subscales: state anxiety and trait anxiety. The total score of each subscale ranges from 20 to 80 points, with higher scores indicating higher levels of anxiety. The Pittsburgh Sleep Quality Index (PSQI) is used to evaluate sleep quality in clinical and basic research, with a total score ranging from 0 to 21 on the PSQI scale. The higher the score, the worse the sleep quality.
Time frame: Baseline and Perioperative.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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