How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

University of Miami

Status: Completed

Conditions: Healthy

Treatments: Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06614933

20240796

Details and patient eligibility

About

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. between the ages of 18-80 years
2. English speaking (must be able to consent and complete the interviews in English)

Exclusion criteria

1. chronic pain (average intensity >2/10 on 0-10 scale, for longer than 3 months)
2. acute pain of intensity greater than 3/10
3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
5. pregnancy
6. currently taking Buprenorphine or recently stopped taking (within 1 month)
7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
8. implants in the head or neck, cochlear implants, or pacemaker
9. head or neck metastasis or recent ear trauma
10. history of epilepsy
11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Biphasic followed by monophasic taVNS group

Experimental group

Description:

Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.

Treatment:

Device: Monophasic transcutaneous auricular vagus nerve stimulation

Device: Biphasic transcutaneous auricular vagus nerve stimulation

Monophasic followed by biphasic taVNS group

Active Comparator group

Description:

Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.

Treatment:

Device: Monophasic transcutaneous auricular vagus nerve stimulation

Device: Biphasic transcutaneous auricular vagus nerve stimulation