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This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Participants also will be asked to complete computer tasks. Because brain activity will be measured, participants will be asked to come to the study with clean, dry hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.
There are some risks to completing this study. Some questions in the surveys ask about personal thoughts and feelings. The ear stimulation may cause tingling sensations or irritation around the ear.
There are no direct benefits to participants. This study will help researchers improve this ear stimulation as a treatment method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Other |
| |
| Dose Group 2 | Other |
| |
| Dose Group 3 | Other |
| |
| Dose Group 4 | Other |
| |
| Dose Group 5 | Other |
| |
| Dose Group 6 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes | Device | Sham 60 minutes and taVNS active stimulation for 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in P300 Amplitude | Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation. | Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes |
| Change in Heart Rate Variability | Baseline to end of Active Stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Group 1 | transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes |
| FG001 | Dose Group 2 | taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes |
| FG002 | Dose Group 3 | taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes |
| FG003 | Dose Group 4 | taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes |
| FG004 | Dose Group 5 | taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Group 1 | transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes |
| BG001 | Dose Group 2 | taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Date of Birth and Reported continuous age |
| 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 | Change in P300 Amplitude | Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation. | Posted | Mean | Standard Deviation | microvolts | Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes |
|
1 Day
Definitions of adverse event and serious adverse event are similar to clinicaltrials.gov.
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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 | Dose Group 1 | transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Taylor, PhD | Wayne State University | 6166486793 | dtaylo@med.wayne.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2022 | Mar 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2021 | Mar 1, 2024 | ICF_001.pdf |
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| taVNS 30 minutes | Device | Sham 45 minutes and taVNS active stimulation for 30 minutes |
|
| taVNS 45 minutes | Device | Sham 30 minutes and taVNS active stimulation for 45 minutes |
|
| taVNS 60 minutes | Device | Sham 15 minutes and taVNS active stimulation for 60 minutes |
|
| taVNS 75 minutes | Device | Sham 0 minutes and taVNS active stimulation for 75 minutes |
|
| taVNS 0 minutes | Device | Sham taVNS 75 minutes |
|
| BG002 | Dose Group 3 | taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes |
| BG003 | Dose Group 4 | taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes |
| BG004 | Dose Group 5 | taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes |
| BG005 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Dose 1- 1 participant declined to report their sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dose Group 3 |
taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes |
| OG003 | Dose Group 4 | taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes |
| OG004 | Dose Group 5 | taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes |
|
|
| Primary | Change in Heart Rate Variability | Posted | Mean | Standard Deviation | ms | Baseline to end of Active Stimulation |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Dose Group 2 | taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Dose Group 3 | taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Dose Group 4 | taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Dose Group 5 | taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes | 0 | 5 | 0 | 5 | 0 | 5 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|