Auricular Stimulation for Healthy Subjects
(NIRAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how auricular stimulation affects brain activity in healthy adults. Researchers will use a special cap with sensors to track brain responses while gently touching specific points on the ears. The study requires only a single visit, so there is no long-term commitment. Candidates should be healthy and have not used pain medications frequently or any drugs recently. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research without long-term involvement.
Will I have to stop taking my current medications?
The trial requires that you do not use opioids, marijuana, or psychoactive prescription medications regularly. If you are using these, you would need to stop before participating.
What prior data suggests that auricular stimulation is safe for healthy subjects?
A previous study found ear stimulation generally safe, with only mild side effects. Common issues included ear pain, headache, and dizziness. Another review found tenderness or minor bleeding might occur at the stimulation site. These effects are usually mild and resolve quickly. Importantly, this type of stimulation doesn't use needles, so the risk of infection remains low. Overall, most people tolerate ear stimulation well.12345
Why are researchers excited about this trial?
Researchers are excited about auricular stimulation because it offers a non-invasive approach to stimulating specific points on the ear that correspond to different body areas, like the shoulder, thumb, and lumbar spine. Unlike traditional treatments that might involve medication or invasive procedures, this method uses flexible plastic filaments to gently stimulate these points, potentially offering relief without the need for drugs. Additionally, the use of a functional near-infrared spectroscopy (fNIRS) cap to record brain responses during stimulation provides valuable insights into how the brain reacts, which could pave the way for new therapeutic applications.
What evidence suggests that auricular stimulation is effective for brain activity measurement?
Research has shown that stimulating specific points on the ear, known as auricular stimulation, can influence brain activity. Studies have found that this type of stimulation can change brain function, particularly in areas related to relaxation and pain relief. For instance, auricular vagus nerve stimulation (aVNS) effectively treats pain and sleep problems. Other research indicates that auricular acupuncture can enhance the brain's ability to adapt and respond to changes, a process called neuroplasticity. These findings suggest that auricular stimulation may improve brain function and certain health conditions. In this trial, participants will undergo auricular stimulation while researchers record brain responses using functional near-infrared spectroscopy (fNIRS).678910
Who Is on the Research Team?
Keith Vogt, MD, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This clinical trial is open to healthy volunteers who want to participate in a single-visit study. There are no specific inclusion or exclusion criteria provided, which suggests that the trial may have broad eligibility.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-visit Study
Participants undergo a single session where brain activity is measured using fNIRS while auricular points are stimulated
Follow-up
Participants are monitored for any immediate adverse effects post-study
What Are the Treatments Tested in This Trial?
Interventions
- Auricular Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor