Healthy Male and Female SubjectsNIRASNCT06825364
Near-InfraRed Spectroscopy of Auricular Stimulation
A study testing auricular stimulation in people with Healthy Male and Female Subjects and Healthy Volunteer Study, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects, Healthy Volunteer Study
- What is being tested?
- auricular stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of at least 18 years
Who cannot join
- frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,
- history or symptoms of neuropathy,
- active lesions or skin disruptions to either ear,
- recent (< 3 mo) illicit drug use,
- history of substance misuse/abuse,
- current or recent (<1 month) opioid or marijuana use, and
- current regular use of psychoactive prescription medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Keith Vogt, MD, PhD, vogtkm@upmc.edu
Amy Monroe, MPH, MBA, 412-623-6382, monroeal@upmc.edu
About this study
Official title: Neural Responses to Tactile Auricular Stimulation Measured by Functional Near-infrared Spectroscopy in Pain-free Volunteers
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.
Read the detailed description
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.
- Being tested
- auricular stimulation
- Keywords
- auricular stimulation, functional near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular stimulationOther
Also called von Frey filament
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: auricular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start12 Aug 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational mechanistic study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith M Vogt, University of Pittsburgh
- Investigators
- Keith Vogt, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825364
- Sponsor's protocol ID
- STUDY24090032
- Acronym
- NIRAS
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be publicly shared, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Responses to Tactile Auricular Stimulation Measured by Functional Near-infrared Spectroscopy in Pain-free Volunteers
- ClinicalTrials.gov ID
- NCT06825364
- Acronym / sponsor ID
- NIRAS / STUDY24090032
- Keywords
- auricular stimulation, functional near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational mechanistic study
| Arm | Type | Receives |
|---|---|---|
| Auricular stim with fNIRS | Experimental | Other: auricular stimulationPoints 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age of at least 18 years
Key exclusion criteria (7 listed)
- frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,
- history or symptoms of neuropathy,
- active lesions or skin disruptions to either ear,
- recent (< 3 mo) illicit drug use,
- history of substance misuse/abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular stimulationAlso: von Frey filamentDifferent 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. | Other | Auricular stim with fNIRS |
Primary outcome
fNIRS response, Lumbar spine vs. thumb auricular points
Time frame: 10 minutes
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.
2 secondary outcomes
fNIRS response, shoulder vs. thumb auricular points
Time frame: 10 minutes
fNIRS response, lumbar spine vs. shoulder auricular points
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be publicly shared, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith Vogt, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular stimulation in people with Healthy Male and Female Subjects and Healthy Volunteer Study, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly Riedmann, MPH (412-623-4147, riedmannca@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fNIRS response, Lumbar spine vs. thumb auricular points (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.