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Investigating the Transcutaneous vs. Transcranial Mechanisms of Trigeminal Nerve Stimulation (eTNS) Using fMRI

RecruitingNAAges 18 Years - 35 YearsAllXidian University
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In plain words

What the trial is, and whether it could suit you

Transcutaneous Trigeminal Nerve Stimulation (eTNS) is a non-invasive technique that modulates brain activity by applying electrical currents to the forehead. However, it remains unclear whether its effects are primarily driven by activating peripheral nerves in the skin (the transcutaneous pathway) or by the electrical current passing directly through the skull into the brain (the transcranial pathway). This study aims to differentiate these two mechanisms in healthy volunteers. Participants will complete two separate MRI scanning sessions. In one session, a local anesthetic (lidocaine) will be applied to numb the skin over the forehead (specifically the supraorbital nerve branch) to temporarily block the peripheral nerve signals. In the other session, no anesthesia will be used. During both sessions, participants will receive active direct current eTNS (DC-eTNS) and a sham (inactive) s

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. Known allergy, hypersensitivity, or adverse reactions to Lidocaine or other amide-type local anesthetics. (Crucial for this specific study design) 2. Contraindications to MRI scanning (e.g., claustrophobia, cardiac pacemakers, artificial cochlea, metallic braces, or any other ferromagnetic implants). 3. Female participants who are pregnant, lactating, or suspect they might be pregnant. 4. Contraindications to transcranial or transcutaneous electrical stimulation (e.g., personal or family history of epilepsy/seizures, implanted brain stimulators). 5. Any active skin disease, inflammation, lesions, cuts, or abrasions on the forehead (specifically over the supraorbital area), which could alter electrical impedance or anesthetic absorption. 6. History of trigeminal neuralgia, facial nerve palsy, or chronic facial pain. Current or recent (within the past month) use of any medications known to affect the central nervous system, autonomic nervous system, or pain perception (e.g., analgesics, antidepressants, beta-blockers, or sedatives). 7. History of substance abuse, heavy smoking, or excessive daily consumption of alcohol or caffeine. 8. Irregular sleep patterns, shift work, or severe sleep deprivation within 24 hours prior to the scanning sessions.
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What it tests

  • Topical Lidocaine
  • Direct Current eTNS (DC-eTNS)
  • Sham DC-eTNS
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Where

1 site
Xidian University
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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