Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation (NCT06782360) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation
United States45 participantsStarted 2025-04-30
Plain-language summary
The goal of this clinical trial is to extend this period of optimal cognitive performance by applying neurostimulation to buffer health volunteers against the effects of increased levels of stress, distraction, and cybersickness. The main questions it aims to answer are:
* Can we use OpenBCI's head-mounted Galea biosensor + eXtended Reality (XR) platform to measure participants' cognitive state in relation to stress, attention and cybersickness?
* How does applying external neurostimulation via Spark Biomedical's Sparrow Link transcutaneous auricular neurostimulation (tAN) system enhance cognitive performance with a closed-loop interface that automatically applies neurostimulation as a function of physiologically determined stress, attention, and cybersickness metrics?
Researchers will compare the active neurostimulation group to the sham neurostimulation group to see if cognitive performance is improved with stimulation.
Participants will complete 4 virtual reality tasks in the lab:
* 2 tasks related to attention - Flanker and Gradual-onset Continual Performance Task (GradCPT)
* The Multi-Attribute Task Battery (MATB)
* A cybersickness task
* And a baseline session before each task
* Neurostimulation intervention will occur in response to cognitive states
Who can participate
Age range
18 Years
Sex
ALL
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:
* Healthy human subjects between the ages of 18 and 55
* Normal color vision and near visual acuity of 20/30 without correction.
* Participant is right-hand dominant
* 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 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 has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
* Current or recent history of substance abuse or drug dependence including nicotine and alcohol, or use of mind-altering drugs in the past 30 days.
* Participant has abnormal ear anatomy, ear infection present, or ear piercing that could interfere with stimulation
* Participant has a recent history of epileptic seizures; including photosensitive epilepsy
* Participant has a recent history of neurologic diseases or traumatic brain injury
* Participant has presence of implanted medical devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
* Females who are pregnant or lactating
* Participant has any other significant disease…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Flanker Task Performance
Timeframe: Baseline, pre-intervention, and during the intervention phases
2
GradCPT Task Performance
Timeframe: Baseline, pre-intervention, and during the intervention phases
3
MATB Task Performance
Timeframe: Baseline, pre-intervention, and during the intervention phases
4
Cybersickness Task Performance
Timeframe: Baseline, pre-intervention, and during the intervention phases