CompletedNot Applicable

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

United States43 participantsStarted 2024-11-26

Plain-language summary

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.

Who can participate

Age range18 Years – 41 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults 18 to 41 years old
✓. Participant has the cognitive and physical abilities to carry out the study tasks
✓. Proficient in the English language
✓. Ability to understand the explanations and instructions given by the study personnel

Exclusion criteria

✕. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
✕. Participant has used any psychological stress-management intervention within the last 4 weeks
✕. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
✕. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
✕. Participant is currently using anti-anxiety medications such as Xanax or beta blockers
✕. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
✕. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
✕. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation

What they're measuring

Match-to-Sample Task (MST)

Timeframe: From baseline to post-stressor (up to 3 hours)

Psychomotor Vigilance Task (PVT)

Timeframe: From baseline to post-stressor (up to 3 hours)

Perdue Pegboard Task (PPT)

Timeframe: From baseline to post-stressor (up to 3 hours)

Maastricht Acute Stress Test (MAST)

Timeframe: After baseline tasks, approximately 35 minutes

Trial details

NCT IDNCT06390267

SponsorSpark Biomedical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-18

View on ClinicalTrials.gov More Acute Stress Reaction trials

Who can participate

Age range18 Years – 41 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults 18 to 41 years old
✓. Participant has the cognitive and physical abilities to carry out the study tasks
✓. Proficient in the English language
✓. Ability to understand the explanations and instructions given by the study personnel

Exclusion criteria

✕. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
✕. Participant has used any psychological stress-management intervention within the last 4 weeks
✕. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
✕. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
✕. Participant is currently using anti-anxiety medications such as Xanax or beta blockers
✕. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
✕. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
✕. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation

What they're measuring

Match-to-Sample Task (MST)

Timeframe: From baseline to post-stressor (up to 3 hours)

Psychomotor Vigilance Task (PVT)

Timeframe: From baseline to post-stressor (up to 3 hours)

Perdue Pegboard Task (PPT)

Timeframe: From baseline to post-stressor (up to 3 hours)

Maastricht Acute Stress Test (MAST)

Timeframe: After baseline tasks, approximately 35 minutes