Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Digitmer High Voltage Stimulator model DS7A TENS unit

Study type: Interventional

Funder types: Other

Identifiers

NCT02835885

Pro00038301

Details and patient eligibility

About

The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the physiological effects of tVNS at different stimulation parameters. The electrical stimulation variables will be pulse width, frequency, and current. This will be tested in a laboratory setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and perceived pain. This is a feasibility and small safety study.

Hypothesis: tVNS is feasible and safe

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meets none of the Exclusion Criteria

Exclusion criteria

• History of seizures, depression, or pain conditions
• Taking any prescription medications (excluding contraceptives and statins)
• History of any ear trauma
• History of heart conditions
• Has a heart pacemaker or artificial valve
• Has a metal implant above the waste
• Is pregnant
• Alcohol Dependence
• Illicit drug use in past 6 months
• History of brain surgery or lesions
• History of loss of consciousness (>15 min)
• Faint at the sight of blood
• Hospitalization or surgeries in past 6 months

Trial design

15 participants in 2 patient groups

Active tVNS Stimulation

Experimental group

Description:

Stimulating electrode will be placed on left tragus of subject. Current will be held constant (200% perceptual threshold) while pulse width and frequency are varied.The intervention used to keep current constant is Digitmer High Voltage Stimulator model DS7A TENS unit. Each stimulation period (9 randomized stimulation parameters varying in pulse width and frequency) will last 1 minute with a 3 minute break between each parameter. Physiological data (O2 saturation, blood pressure, breathing rate, and Electrocardiogram (EKG) to measure heart rate ) will be collected continuously.

Treatment:

Device: Digitmer High Voltage Stimulator model DS7A TENS unit

Sham tVNS Stimulation

Sham Comparator group

Description:

Stimulating electrode will be placed on left ear lobe of subject for sham tVNS stimulation condition. Current will be held constant (200% perceptual threshold) while pulse width and frequency are varied. The intervention used to keep current constant is Digitmer High Voltage Stimulator model DS7A TENS unit. Each stimulation period (9 randomized stimulation parameters varying in pulse width and frequency) will last 1 minute with a 3 minute break between each parameter. Physiological data (O2 saturation, blood pressure, breathing rate, and Electrocardiogram (EKG) to measure heart rate ) will be collected continuously.

Treatment:

Device: Digitmer High Voltage Stimulator model DS7A TENS unit