Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06825364

Conditions

Healthy Male and Female Subjects

Healthy Volunteer Study

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

auricular stimulation

Study Details

Brief 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.

Conditions

Healthy Male and Female Subjects

Healthy Volunteer Study

Study ID

NCT06825364

Start date

Aug 12, 2025

Status verified date

Feb, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Auricular stim with fNIRS

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.

Interventions

auricular stimulation

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.

Primary outcome measure

  • fNIRS response, Lumbar spine vs. thumb auricular points [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Keith Vogt, MD, PhD

vogtkm@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • auricular stimulation
  • functional near infrared spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-18.