Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Active tVNS Stimulation
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.
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Comparador falso: Sham tVNS Stimulation
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Periodo de tiempo: Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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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. |
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Periodo de tiempo: Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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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. |
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Periodo de tiempo: Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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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. |
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Periodo de tiempo: 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. |
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Periodo de tiempo: 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 Blood Pressure (mmHg) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter. |
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Periodo de tiempo: 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 Blood Pressure (mmHg) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter. |
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
Periodo de tiempo: 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 breathing rate (%CO2) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter. |
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
Periodo de tiempo: 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 breathing rate (%CO2) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter. |
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Pro00038301
Plan de datos de participantes individuales (IPD)
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