Near-InfraRed Spectroscopy of Auricular Stimulation (NIRAS)

University of Pittsburgh

Status: Enrolling

Conditions: Healthy Male and Female Subjects; Healthy Volunteer Study

Treatments: Other: auricular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06825364

STUDY24090032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age of at least 18 years

Exclusion criteria

1. frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,
2. history or symptoms of neuropathy,
3. active lesions or skin disruptions to either ear,
4. recent (< 3 mo) illicit drug use,
5. history of substance misuse/abuse,
6. current or recent (<1 month) opioid or marijuana use, and
7. current regular use of psychoactive prescription medications

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Auricular stim with fNIRS

Experimental group

Description:

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.

Treatment:

Other: auricular stimulation