Personalized TMS to Test Heart-Brain Linking in People with Depressive Tendencies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory, randomized, single-blind, sham-controlled, within-subject crossover study uses 3T MRI to map each participant's brain connectivity and then applies four TMS conditions (individualized DLPFC-sgACC, individualized DLPFC-insula, standard F3, and sham) in randomized order. EEG and ECG are recorded before, during, and after stimulation to explore neural and cardiac responses and underlying mechanisms. Participants include adults aged 18–30 with depressive tendencies and healthy controls, with sessions spaced at least five days apart. The aim is to understand how targeted brain stimulation can modulate heart-brain coupling in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xidian University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Xue-Juan, Yang
• Email: xjyang@xidian.edu.cn
• Phone: 13227038185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.