How different eTNS frequencies affect brain activity and autonomic function in healthy volunteers

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

In this randomized, sham-controlled crossover study, healthy volunteers undergo fMRI while receiving three conditions: 2 Hz eTNS, 120 Hz eTNS, and sham stimulation. Each session uses a block design with 30-second stimulation periods alternating with 30-second breaks, and includes structural and functional MRI sequences at 3T. Throughout scanning, physiological data such as respiration and heart rate are continuously recorded to examine central-autonomic coupling. Primary analyses focus on BOLD responses and functional connectivity changes, with secondary assessments of autonomic metrics like heart rate variability. The study explores how stimulation frequency may modulate brain networks and autonomic regulation in a healthy population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy volunteers, aged 18 to 40 years old.
2. Right-handed.
3. Generally healthy with no history of neurological, psychiatric, or severe cardiovascular diseases.
4. Normal physical and neurological examinations.
5. Capable of understanding the study procedures and voluntarily signing the written informed consent form.

Exclusion Criteria:

1. Contraindications to MRI scanning (e.g., claustrophobia, cardiac pacemakers, artificial cochlea, metallic braces, or any other ferromagnetic implants).
2. Female participants who are pregnant, lactating, or suspect they might be pregnant.
3. Contraindications to transcutaneous electrical stimulation (e.g., personal or family history of epilepsy/seizures, trigeminal neuralgia, facial skin lesions, or active skin diseases on the forehead).
4. Current or recent (within the past month) use of any medications known to affect the central nervous system or the autonomic nervous system (e.g., antidepressants, beta-blockers, sedatives, or sympathomimetics).
5. History of substance abuse, heavy smoking, or excessive daily consumption of alcohol or caffeine.
6. Irregular sleep patterns, shift work, or severe sleep deprivation within 24 hours prior to the scanning session.

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.