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Depression DisorderNCT07753473

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

A study testing DLPFC-insula TMS, DLPFC-sgACC TMS and 10-20 F3 TMS in people with Depression Disorder and fMRI Research, run by Xidian University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
DLPFC-insula TMS, DLPFC-sgACC TMS and 10-20 F3 TMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
1 Aug 2026to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 一、Inclusion criteria for the depressed group:
  • Aged 18-30 years;
  • Recent feelings of low mood and presence of depressive symptoms;
  • Physically healthy, with no history of neurological disorders;
  • No participation in other neuromodulation experiments within the past month;
  • Normal hearing and normal (or corrected-to-normal) vision;
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  • PHQ-9 score > 5 and BDI-II score > 13;
  • Avoidance of staying up late, alcohol consumption, and excessive caffeine intake prior to the experiment;
  • Able and willing to cooperate with the completion of scale assessments. 二、Inclusion criteria for healthy participants:
  • 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.

Who cannot join

  • History of head trauma (including neurosurgery), stroke, elevated intracranial pressure, or other brain-related disorders;
  • History of epileptic seizures or family history of epilepsy;
  • Receipt of TMS or other neuromodulation stimulation within the past month;
  • Presence of intracranial or internal metallic foreign bodies, electrodes made of silver or gold, or metal prostheses;
  • Presence of devices potentially affected by TMS, such as pacemakers, drug pumps, cochlear implants, or implanted brain stimulators;
  • Severe or recent cardiac, pulmonary, or hematopoietic system disorders, or other neurological diseases;
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  • Clinically diagnosed moderate-to-severe depressive disorder;
  • Substance abuse, alcohol dependence, etc.;
  • Current active suicidal ideation or suicidal behavior; Refusal to sign the informed consent form.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xue-Juan, Yang contact

13227038185

xjyang@xidian.edu.cn

China1 site, 1 recruiting
  • Xidian University

    Xi'an, Shaanxi, 71000

    Xue-Juan Yang, 13227038185, xjyang@xidian.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Study on the Regulation of Heart-Brain Coupling in Individuals With Depressive Tendencies Using Transcranial Magnetic Stimulation (TMS) Based on Personalized Functional Connectivity

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.

Read the detailed description

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.

Being tested
DLPFC-insula TMS, DLPFC-sgACC TMS, 10-20 F3 TMS, sham TMS
Keywords
Functional Connectivity, Individualized treatment, Transcranial magnetic stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLPFC-insula TMSDevice

    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 TMSDevice

    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 TMSDevice

    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 TMSDevice

    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 groups in NCT07753473
Study groupRoleWhat they receive
Personalized stimulation targeting the functional connectivity between the DLPFC-sgACC.ExperimentalAt 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.
Receives: Device: DLPFC-sgACC TMS
Personalized stimulation targeting DLPFC-insula functional connectivityExperimentalAt 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.
Receives: Device: DLPFC-insula TMS
Standard F3 Target StimulationExperimentalAt 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.
Receives: Device: 10-20 F3 TMS
sham stimulationSham comparatorAt 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.
Receives: Device: sham TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Perioperative. During the 7-minute-22-second treatment period under each stimulation condition.

  2. 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."

    Measured: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.

  3. 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.

    Measured: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.

Secondary outcomes (3)
  1. 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.

    Measured: Perioperative period. Specifically, within 10 minutes before and after each stimulus condition.

  2. 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.

    Measured: Baseline. During the 6-minute-30-second fMRI scan.

  3. 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.

    Measured: Baseline and Perioperative.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753473
Sponsor's protocol ID
20260721
Status last verified
Aug 2026
First submitted
30 Jul 2026
Last updated
7 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DLPFC-insula TMS, DLPFC-sgACC TMS and 10-20 F3 TMS in people with Depression Disorder and fMRI Research, run by Xidian University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xue-Juan, Yang (13227038185, xjyang@xidian.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TMS-induced heart-brain coupling (time frame: Perioperative. During the 7-minute-22-second treatment period under each stimulation condition.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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