Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

Healthy Clinical Trial

Official title:

How Does the Length of Pulse Trains and Pulse Intervals Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381102
• Other study ID #: 20240134
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Marlon Wong, DPT, PhD
• Phone: 305-243-8117
• Email: mwong2[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• transcutaneous auricular vagus nerve stimulation 30/30
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 30 second on and 30 second off, for 1 hour, in-person.
• transcutaneous auricular vagus nerve stimulation 10/10
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 10 second on and 10 second off, for 1 hour, in-person.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability measured by tolerability questionnaire	Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort)-10 (worst pain imaginable) for comfort.	Up to 3 hours.
Primary	Tolerability measured by self-report	Tolerability will be assessed using semi-structured interviews. Investigators will ask about the sensations experienced and preferences. Participants will self-report their responses.	Up to 3 hours.
Secondary	Change in heart rate variability (HRV)	HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.	Baseline and up to 3 hours.