Near-InfraRed Spectroscopy of Auricular Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
auricular stimulation
Other interventionDifferent 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Auricular stim with fNIRSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutesSecondary outcomes
1
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.
Time frame
10 minutes2
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.
Time frame
10 minutesSponsors and contacts
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Source ClinicalTrials.gov