Using auricular neurostimulation to improve cognitive performance under stress
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
This study is testing if a new type of ear stimulation can help healthy adults think better when they are feeling stressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | All |
| Sponsor | Spark Biomedical, Inc. Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06390267 on ClinicalTrials.gov |
What this trial studies
This study tests the effects of transcutaneous auricular neurostimulation (tAN) on cognitive performance in healthy adults experiencing acute stress. It is a randomized, double-blind, sham-controlled trial involving sixty participants who will be divided into four groups to receive either active or sham tAN treatment before or during a stress test. Participants will perform cognitive tasks before and after the intervention while biosensors collect biomarker data. The aim is to determine if tAN can prevent performance degradation due to stress.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 41 who can perform cognitive tasks and understand English.
Not a fit: Patients with significant medical or psychiatric conditions, or those currently using anti-anxiety medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive resilience in stressful situations for patients.
How similar studies have performed: While the specific application of tAN in this context is novel, similar neurostimulation approaches have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18 to 41 years old 2. Participant has the cognitive and physical abilities to carry out the study tasks 3. Proficient in the English language 4. Ability to understand the explanations and instructions given by the study personnel Exclusion Criteria: 1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition 2. Participant has used any psychological stress-management intervention within the last 4 weeks 3. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial 4. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder 5. Participant is currently using anti-anxiety medications such as Xanax or beta blockers 6. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD. 7. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months 8. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation 9. Participant has a history of epileptic seizures 10. Participant has a history of neurologic diseases or traumatic brain injury 11. Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators) 12. Females who are pregnant or lactating 13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Where this trial is running
Columbus, Ohio
- Battelle Memorial Institute — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Philip Putnam, PhD — Battelle Memorial Institute
- Study coordinator: Mary Heimann
- Email: neuromod@battelle.org
- Phone: 614-424-3043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.