Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation

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

Conditions

• Healthy
• Cognitive Change
• Effects of External Neurostimulation on Cognition

Interventions

DEVICE

Active 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.

DEVICE

Sham Stimulation

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

Sponsors & Collaborators

• Spark Biomedical, Inc.

  collaborator INDUSTRY

• OpenBCI

  lead INDUSTRY

Principal Investigators

• Musa Mahmood, PhD · OpenBCI

• Zoe Steine-Hanson, PhD · OpenBCI

• Alejandro Covalin, PhD · Spark Biomedical

• Navid Khodaparast, PhD · Spark Biomedical

• Conor Russomanno, Masters · OpenBCI

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2026-02-13

Completion

2026-03-15

Countries

• United States

Study Locations