Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

Launched by SPARK BIOMEDICAL, INC. · Apr 28, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a treatment called transcutaneous auricular neurostimulation (tAN) on how well people perform under stress. The goal is to see if this method can help improve cognitive performance, like memory and focus, after experiencing acute stress, which is a sudden and intense stress reaction.

To participate in this study, you need to be an adult aged 18 to 41 who is right-handed and speaks English well enough to understand the instructions. You should also be able to complete the tasks required in the study. However, there are some important exclusions; for example, if you have certain medical or psychiatric conditions, have used stress-management techniques recently, or are on specific medications, you may not be eligible. If you join the study, you can expect to take part in tasks designed to measure how well you think and perform under stress while using the tAN treatment. This trial is currently recruiting participants, so if you meet the criteria and are interested, it could be a great opportunity to contribute to research aimed at helping people manage stress better.

Gender

ALL

Eligibility 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