Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Primary Endpoint
- Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Time Frame: Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz. Baseline physiological data O2 saturation (%oxygen) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Time Frame: Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz. Baseline physiological data,Electrocardiogram (EKG) to measure heart rate in beats/sec will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Time Frame: Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz. Baseline physiological data,Electrocardiogram (EKG) to measure heart rate in beats/sec will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Time Frame: Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz. Baseline physiological data O2 saturation (% oxygen) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Secondary Outcomes
- Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1(Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between))
- Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2(Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between))
- Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2(Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between))
- Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1(Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between))