Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation
CAMSAN: Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation
OpenBCI
50 participants
Apr 30, 2025
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
Inclusion Criteria5
- 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 Criteria13
- 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 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
- Sensitivity to bright screens or virtual reality displays
- Recent history of neurological and psychiatric disease/disorder
Interventions
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.
Modulation of stimulation frequency and amplitudes outside of the known physiological effective ranges during intervention periods.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06782360