RecruitingNot ApplicableNCT06782360

Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation

CAMSAN: Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation


Sponsor

OpenBCI

Enrollment

50 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether gentle electrical stimulation applied to the ear (auricular neurostimulation) combined with brain monitoring technology can temporarily boost working memory and cognitive performance in healthy adults. The goal is to improve mental focus and information-processing speed. **You may be eligible if...** - You are between 18 and 55 years old - You are right-handed - You are in good physical and mental health - You are fluent in English - You have normal near-vision (corrected or uncorrected) and normal color vision **You may NOT be eligible if...** - You have a history of PTSD, anxiety disorder, or ADHD - You have a history of epilepsy or seizures - You have recently used any mind-altering substances or drugs - You have an ear infection, abnormal ear anatomy, or ear piercings that could interfere with stimulation - You are currently in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive Neurostimulation

The stimulation frequency, pulse width, and amplitude will be varied in order to determine the optimal stimulation conditions for elongating the period of peak subject performance during the experimental tasks. Amplitude, pulse width, and frequency meet or exceed International Electrotechnical Commission (IEC) 60601-2-10:2016 requirements. The amplitude range specified is selectable for either channel with any frequency and pulse width combination. We will test an amplitude range of 0 mA - 5.0 mA. We will test a frequency range of 1 Hz - 150 Hz. We will test a pulse width range of 50 μs - 750 μs. The study coordinator should apply neurostimulation when the reported cognitive state metric corresponding to the performance task reaches different thresholds. These thresholds will be determined before execution of the study and will be chosen to maximize the likelihood of discovering an optimal trigger for neurostimulation based on reported cognitive state.

DEVICESham Stimulation

Modulation of stimulation frequency and amplitudes outside of the known physiological effective ranges during intervention periods.


Locations(1)

OpenBCI

Brooklyn, New York, United States

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NCT06782360


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