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| ID | Type | Description | Link |
|---|---|---|---|
| 5R25DA020537-15 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS then Sham taVNS | Experimental | Participants will receive active then sham (placebo) ear stimulation. |
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| Sham taVNS then Active taVNS | Experimental | Participants will receive sham (placebo) then active ear stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active taVNS | Device | Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Heart Rate (Before CPT/taVNS) | Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation. | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
| Mean Heart Rate (During CPT/taVNS) | Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation. | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
| Mean Heart Rate (After CPT/taVNS) | Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation. | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of Pain (Before CPT/taVNS) | Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) before concurrent stress test and ear stimulation. | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
| Mean Score of Pain (During CPT/taVNS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher W Austelle, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants were excluded for any major medical comorbidities, as this study only enrolled healthy neurotypical participants. Upon enrollment, participants were automatically randomized to receive active taVNS or sham stimulation first (all participants received both active and sham, the order was randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active taVNS Then Sham taVNS | Participants will receive active then sham (placebo) ear stimulation. Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
| FG001 | Sham taVNS Then Active taVNS | Participants will receive sham (placebo) then active ear stimulation. Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active taVNS Then Sham taVNS | Participants will receive active then sham (placebo) ear stimulation. Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Heart Rate (Before CPT/taVNS) | Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | beats per minute | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active taVNS | Participants will receive active ear stimulation. Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher W. Austelle | Medical University of South Carolina | 843-792-2872 | austelle@musc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2021 | Jan 4, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2022 | Jan 10, 2024 | ICF_002.pdf |
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| Sham taVNS | Device | Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
|
Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) during concurrent stress test and ear stimulation. |
| During concurrent stress test and ear stimulation (average duration of 5 minutes) |
| Mean Score of Pain (After CPT/taVNS) | Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) after concurrent stress test and ear stimulation. | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
| Mean Score of Anxiety (Before CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) before concurrent stress test and ear stimulation. | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
| Mean Score of Anxiety (During CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) during concurrent stress test and ear stimulation. | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
| Mean Score of Anxiety (After CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) after concurrent stress test and ear stimulation. | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
| Mean Score of Distress (Before CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) before concurrent stress test and ear stimulation. | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
| Mean Score of Distress (During CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) during concurrent stress test and ear stimulation. | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
| Mean Score of Distress (After CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) after concurrent stress test and ear stimulation. | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
| BG001 | Sham taVNS Then Active taVNS | Participants will receive sham (placebo) then active ear stimulation. Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Sham taVNS |
Participants will receive sham (placebo) ear stimulation. Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. |
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| Primary | Mean Heart Rate (During CPT/taVNS) | Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | beats per minute | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
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| Primary | Mean Heart Rate (After CPT/taVNS) | Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | beats per minute | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Pain (Before CPT/taVNS) | Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) before concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Pain (During CPT/taVNS) | Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) during concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
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| Secondary | Mean Score of Pain (After CPT/taVNS) | Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) after concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Anxiety (Before CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) before concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Anxiety (During CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) during concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
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| Secondary | Mean Score of Anxiety (After CPT/taVNS) | Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) after concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Distress (Before CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) before concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation) |
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| Secondary | Mean Score of Distress (During CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) during concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | During concurrent stress test and ear stimulation (average duration of 5 minutes) |
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| Secondary | Mean Score of Distress (After CPT/taVNS) | Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) after concurrent stress test and ear stimulation. | Posted | Mean | Standard Deviation | units on a scale | After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation) |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Sham taVNS | Participants will receive sham (placebo) ear stimulation. Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation. | 0 | 21 | 0 | 21 | 0 | 21 |
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