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This is a single-visit non-invasive study of healthy volunteer subjects. Brain activity will be measured with infra-red light sensors attached to a cap worn on the head, while both ears are gently stimulated with plastic filaments.
The aim of this study is to localize and quantify brain activations from experimental stimulation of auricular points in pain-free volunteers. Investigators will stimulate auricular points for the shoulder, thumb, and lumbar spine with von Frey filaments and measure functional near-infrared spectroscopy (fNIRS) responses in the primary somatosensory (S1) and prefrontal cortex (PFC). This will test the hypothesis that stimulation across different points in the auricular cartography maps to distinct brain responses, an assumption underpinning AT theory. Stimulation of different ear points is anticipated to induce similar PFC responses, but activate distinct areas within the S1 homunculus, validating the concept of auricular cartography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular stim with fNIRS | Experimental | Points on the ear that correspond to the the shoulder, thumb, and lumbar spine (within an accepted cartography for auriculotherapy) will be stimulated repeatedly with flexible plastic (von Frey) filaments. A functional near-infrared spectroscopy cap will be worn, and brain responses to the stimulation will be recorded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auricular stimulation | Other | Different points on both ears will be repeatedly stimulated with a plastic filament. This will be felt, but not be painful and should not result in lasting irritation. |
| Measure | Description | Time Frame |
|---|---|---|
| fNIRS response, Lumbar spine vs. thumb auricular points | Calculated T-statistic for contrast of analyzed fNIRS signal change, comparing responses from stimulation of the ipsilateral ear at the auricular points corresponding to the lumbar-spine vs. thumb. A T-statistic of 0 indicates no difference; more positive scores mean stronger fNIRS signal change with stimulation of the lumbar point, compared to stimulation of the thumb point; more negative scores mean change with stimulation of the thumb, compared to the lumbar spine. This outcome is a number reflecting the overall magnitude of difference between stimulation points, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| fNIRS response, shoulder vs. thumb auricular points | Calculated T-statistic for contrast of analyzed fNIRS signal change, comparing responses from stimulation of the ipsilateral ear at the auricular points corresponding to the shoulder vs. thumb. A T-statistic of 0 indicates no difference; more positive scores mean stronger fNIRS signal change with stimulation of the shoulder, compared to stimulation of the thumb point; more negative scores mean change with stimulation of the thumb, compared to the shoulder. This outcome is a number reflecting the overall magnitude of difference between stimulation points, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework. |
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Inclusion Criteria:
Age of at least 18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Riedmann, MPH | Contact | 412-623-4147 | riedmannca@upmc.edu | |
| Amy Monroe, MPH, MBA | Contact | 412-623-6382 | monroeal@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keith Vogt, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data collected during the trial will be publicly shared, after deidentification.
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Individual participant data are anticipated to be available via open-access database within one year of study completion.
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Observational mechanistic study
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| 10 minutes |
| fNIRS response, lumbar spine vs. shoulder auricular points | Calculated T-statistic for contrast of analyzed fNIRS signal change, comparing responses from stimulation of the ipsilateral ear at the auricular points corresponding to the lumbar-spine vs. shoulder. A T-statistic of 0 indicates no difference; more positive scores mean stronger fNIRS signal change with stimulation of the lumbar point, compared to stimulation of the shoulder point; more negative scores mean change with stimulation of the shoulder, compared to the lumbar spine. This outcome is a number reflecting the overall magnitude of difference between stimulation points, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework. | 10 minutes |