Frequency-Dependent Effects of Auricular Vagus Nerve Stimulation on Autonomic and Cardiovascular Parameters (AVNS-DRC)

SEFA HAKTAN HATIK

Status: Not yet enrolling

Conditions: Healthy Volunteers; Respiration; Vagus Nerve Stimulation; Autonomic Nervous System; Heart Rate; Blood Pressure

Treatments: Device: Pulsetto FIT™ - Sham tcVNS; Device: Pulsetto FIT™ - tcVNS 50 Hz; Device: Pulsetto FIT™ - tcVNS 25 Hz; Device: Pulsetto FIT™ - tcVNS 100 Hz; Device: Pulsetto FIT™ - tcVNS 10 Hz

Study type: Interventional

Funder types: Other

Identifiers

NCT07274332

IRB Number (Pending) (Registry Identifier)

tcVNS1

Details and patient eligibility

About

This randomized, sham-controlled, crossover study investigates the acute autonomic effects of transcutaneous cervical vagus nerve stimulation (tcVNS) applied at five different frequencies (0 Hz/sham, 10 Hz, 25 Hz, 50 Hz, 100 Hz) in healthy adults. The primary objective is to determine how stimulation frequency modulates heart rate variability (HRV), blood pressure, and respiratory rate. The study aims to establish a frequency-specific dose-response model using validated physiological measurements.

Full description

Transcutaneous cervical vagus nerve stimulation (tcVNS) is a non-invasive neuromodulation technique capable of activating afferent vagal pathways projecting to autonomic brainstem nuclei. Although previous studies demonstrate tcVNS-related modulation of autonomic functions, the frequency-response relationship remains insufficiently explored.

This crossover trial randomizes participants to receive five stimulation conditions (sham, 10 Hz, 25 Hz, 50 Hz, 100 Hz) in counterbalanced order. HRV (Polar H10), blood pressure (Omron), and respiratory rate (Kinovea-based thoracoabdominal video tracking) are collected pre- and post-stimulation. Washout between sessions is ≥48 hours.

The study provides one of the first systematic evaluations of frequency-dependent tcVNS effects in healthy adults.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-30 years
• Healthy (self-reported)
• No cardiovascular, neurological, metabolic or psychiatric disorders
• No regular medication affecting autonomic function
• Non-smoker
• BMI 18-29.9

Exclusion criteria

• Pregnancy
• Cardiac arrhythmia
• Hypertension or hypotension
• Chronic respiratory disorders
• Active infection
• Metal implants in cervical area
• Epilepsy
• Syncope history
• Prior vagus stimulation experience

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 5 patient groups

1 - Sham (0 Hz)

Sham Comparator group

Description:

Intervention Type: Pulsetto FIT™ tcVNS Device Intervention Name: Sham tcVNS Description: Device placed on bilateral cervical region; no electrical current delivered. Dose: 10 minutes

Treatment:

Device: Pulsetto FIT™ - Sham tcVNS

2 - 10 Hz tcVNS

Experimental group

Description:

Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (10 Hz) Description: Bilateral cervical stimulation at 10 Hz, 250 μs pulse width. Duration: 10 minutes

Treatment:

Device: Pulsetto FIT™ - tcVNS 10 Hz

3 - tcVNS 25 Hz

Experimental group

Description:

Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (25 Hz) Description: Bilateral cervical stimulation at 25 Hz, 250 μs pulse width. Duration: 10 minutes

Treatment:

Device: Pulsetto FIT™ - tcVNS 25 Hz

4 - tcVNS 50 Hz

Experimental group

Description:

Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (50 Hz) Description: Bilateral cervical stimulation at 50 Hz, 250 μs pulse width. Duration: 10 minutes

Treatment:

Device: Pulsetto FIT™ - tcVNS 50 Hz

5 - tcVNS 100 Hz

Experimental group

Description:

Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (100 Hz) Description: Bilateral cervical stimulation at 100 Hz, 250 μs pulse width. Duration: 10 minutes

Treatment:

Device: Pulsetto FIT™ - tcVNS 100 Hz