Near-InfraRed Spectroscopy of Auricular Stimulation

NCT ID: NCT06825364

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2028-03-30

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.

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.

Conditions

Healthy Male and Female Subjects; Healthy Volunteer Study

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

auricular stimulation

Intervention Type: 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.

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.

Intervention Type: OTHER

Other Intervention Names

von Frey filament

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Keith M Vogt

Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Vogt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carly Riedmann, MPH

Role: CONTACT

riedmannca@upmc.edu

412-623-4147

Amy Monroe, MPH, MBA

Role: CONTACT

monroeal@upmc.edu

412-623-6382

Facility Contacts

Keith Vogt, MD, PhD

Role: primary

vogtkm@upmc.edu

Amy Monroe, MPH, MBA

Role: backup

monroeal@upmc.edu

412-623-6382

Other Identifiers

STUDY24090032

Identifier Type: -

Identifier Source: org_study_id