NCT06825364

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Aug 2025Feb 2028

First Submitted

Initial submission to the registry

February 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

February 7, 2025

Last Update Submit

February 13, 2026

Conditions

Healthy Male and Female SubjectsHealthy Volunteer Study

Keywords

auricular stimulationfunctional near infrared spectroscopy

Outcome Measures

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.

    10 minutes

Secondary Outcomes (2)

  • fNIRS response, shoulder vs. thumb auricular points

    10 minutes

  • fNIRS response, lumbar spine vs. shoulder auricular points

    10 minutes

Study Arms (1)

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.

Other: auricular stimulation

Interventions

auricular stimulationOTHER

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.

Also known as: von Frey filament
Auricular stim with fNIRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of at least 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

  • Keith Vogt, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Riedmann, MPH

CONTACT

412-623-4147riedmannca@upmc.edu

Amy Monroe, MPH, MBA

CONTACT

412-623-6382monroeal@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Observational mechanistic study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 13, 2025

Study Start

August 12, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial will be publicly shared, after deidentification.

Time Frame
Individual participant data are anticipated to be available via open-access database within one year of study completion.

Locations

US(1)