Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation

NCT06782360 | Recruiting

• 2 other identifiers: OBCI-CAMSAN-01 20241050FA238423PB017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cognitive performance; neurostimulation; stress; attention; cybersickness; biosensing

Outcome Measures

Primary Outcomes (4)

• Flanker Task Performance

  Performance will be measured by number of correct responses and reaction time. Specially we will look at mean change in score (percentage of correct responses) and reduction in reaction time.

  Baseline, pre-intervention, and during the intervention phases

• GradCPT Task Performance

  Performance will be measured by number of correct responses and reaction time. Specially we will look at mean change in score (percentage of correct responses) and reduction in reaction time.

  Baseline, pre-intervention, and during the intervention phases

• MATB Task Performance

  Performance will be measured by number of correct responses and performance in the resource management task. Specially we will look at mean task completion percentage and root mean squared error in resource management task.

  Baseline, pre-intervention, and during the intervention phases

• Cybersickness Task Performance

  Performance will be measured by time in experiment. Specifically we will look at mean time before cybersickness symptoms present and mean time before participants voluntarily discontinue the experiment.

  Baseline, pre-intervention, and during the intervention phases

Secondary Outcomes (3)

• Bedford Work Scale Responses

  Baseline, pre-intervention, and during the intervention phases

• Simulator Sickness Questionnaire (SSQ) Responses

  Baseline, pre-intervention, and during the intervention phases

• Baxter Retching Faces (BARF) Responses

  Baseline, pre-intervention, and during the intervention phases

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

The sham group will receive a device but no stimulation will be delivered.

Device: Sham Stimulation

Active tAN

EXPERIMENTAL

This group receives active neurostimulation at different intervals, amplitudes, and frequencies via the Sparrow Link device.

Device: Active Neurostimulation

Interventions

Active Neurostimulation DEVICE

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.

Active tAN

Sham Stimulation DEVICE

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

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OpenBCI: lead
• Spark Biomedical, Inc.: collaborator

Study Sites (1)

OpenBCI

Brooklyn, New York, 11222, United States

RECRUITING

Related Publications (34)

• Kiryu T, So RH. Sensation of presence and cybersickness in applications of virtual reality for advanced rehabilitation. J Neuroeng Rehabil. 2007 Sep 25;4:34. doi: 10.1186/1743-0003-4-34.

  PMID: 17894857 BACKGROUND

• Ylikoski J, Markkanen M, Pirvola U, Lehtimaki JA, Ylikoski M, Jing Z, Sinkkonen ST, Makitie A. Stress and Tinnitus; Transcutaneous Auricular Vagal Nerve Stimulation Attenuates Tinnitus-Triggered Stress Reaction. Front Psychol. 2020 Sep 17;11:570196. doi: 10.3389/fpsyg.2020.570196. eCollection 2020.

  PMID: 33041937 BACKGROUND

• Yasemin M, Sarikaya MA, Ince G. Emotional State Estimation using Sensor Fusion of EEG and EDA. Annu Int Conf IEEE Eng Med Biol Soc. 2019 Jul;2019:5609-5612. doi: 10.1109/EMBC.2019.8856895.

  PMID: 31947127 BACKGROUND

• Wierda SM, van Rijn H, Taatgen NA, Martens S. Pupil dilation deconvolution reveals the dynamics of attention at high temporal resolution. Proc Natl Acad Sci U S A. 2012 May 29;109(22):8456-60. doi: 10.1073/pnas.1201858109. Epub 2012 May 14.

  PMID: 22586101 BACKGROUND

• Vescio B, Salsone M, Gambardella A, Quattrone A. Comparison between Electrocardiographic and Earlobe Pulse Photoplethysmographic Detection for Evaluating Heart Rate Variability in Healthy Subjects in Short- and Long-Term Recordings. Sensors (Basel). 2018 Mar 13;18(3):844. doi: 10.3390/s18030844.

  PMID: 29533990 BACKGROUND

• Trevino M, Zhu X, Lu YY, Scheuer LS, Passell E, Huang GC, Germine LT, Horowitz TS. How do we measure attention? Using factor analysis to establish construct validity of neuropsychological tests. Cogn Res Princ Implic. 2021 Jul 22;6(1):51. doi: 10.1186/s41235-021-00313-1.

  PMID: 34292418 BACKGROUND

• Solhjoo S, Haigney MC, McBee E, van Merrienboer JJG, Schuwirth L, Artino AR Jr, Battista A, Ratcliffe TA, Lee HD, Durning SJ. Heart Rate and Heart Rate Variability Correlate with Clinical Reasoning Performance and Self-Reported Measures of Cognitive Load. Sci Rep. 2019 Oct 11;9(1):14668. doi: 10.1038/s41598-019-50280-3.

  PMID: 31604964 BACKGROUND

• Sharon O, Fahoum F, Nir Y. Transcutaneous Vagus Nerve Stimulation in Humans Induces Pupil Dilation and Attenuates Alpha Oscillations. J Neurosci. 2021 Jan 13;41(2):320-330. doi: 10.1523/JNEUROSCI.1361-20.2020. Epub 2020 Nov 19.

  PMID: 33214317 BACKGROUND

• Ruhnau P, Zaehle T. Transcranial Auricular Vagus Nerve Stimulation (taVNS) and Ear-EEG: Potential for Closed-Loop Portable Non-invasive Brain Stimulation. Front Hum Neurosci. 2021 Jun 14;15:699473. doi: 10.3389/fnhum.2021.699473. eCollection 2021.

  PMID: 34194308 BACKGROUND

• Robertson IH, Manly T, Andrade J, Baddeley BT, Yiend J. 'Oops!': performance correlates of everyday attentional failures in traumatic brain injured and normal subjects. Neuropsychologia. 1997 Jun;35(6):747-58. doi: 10.1016/s0028-3932(97)00015-8.

  PMID: 9204482 BACKGROUND

• Morton J, Zheleva A, Van Acker BB, Durnez W, Vanneste P, Larmuseau C, De Bruyne J, Raes A, Cornillie F, Saldien J, De Marez L, Bombeke K. Danger, high voltage! Using EEG and EOG measurements for cognitive overload detection in a simulated industrial context. Appl Ergon. 2022 Jul;102:103763. doi: 10.1016/j.apergo.2022.103763. Epub 2022 Apr 8.

  PMID: 35405457 BACKGROUND

• Molefi E, McLoughlin I, Palaniappan R. On the potential of transauricular electrical stimulation to reduce visually induced motion sickness. Sci Rep. 2023 Feb 25;13(1):3272. doi: 10.1038/s41598-023-29765-9.

  PMID: 36841838 BACKGROUND

• Miller AL, Unsworth N. Variation in attention at encoding: Insights from pupillometry and eye gaze fixations. J Exp Psychol Learn Mem Cogn. 2020 Dec;46(12):2277-2294. doi: 10.1037/xlm0000797. Epub 2019 Nov 21.

  PMID: 31750720 BACKGROUND

• Mercante B, Deriu F, Rangon CM. Auricular Neuromodulation: The Emerging Concept beyond the Stimulation of Vagus and Trigeminal Nerves. Medicines (Basel). 2018 Jan 21;5(1):10. doi: 10.3390/medicines5010010.

  PMID: 29361732 BACKGROUND

• McDuff D, Gontarek S, Picard R. Remote measurement of cognitive stress via heart rate variability. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:2957-60. doi: 10.1109/EMBC.2014.6944243.

  PMID: 25570611 BACKGROUND

• Lindsay GW. Attention in Psychology, Neuroscience, and Machine Learning. Front Comput Neurosci. 2020 Apr 16;14:29. doi: 10.3389/fncom.2020.00029. eCollection 2020.

  PMID: 32372937 BACKGROUND

• Landolt K, Maruff P, Horan B, Kingsley M, Kinsella G, O'Halloran PD, Hale MW, Wright BJ. Chronic work stress and decreased vagal tone impairs decision making and reaction time in jockeys. Psychoneuroendocrinology. 2017 Oct;84:151-158. doi: 10.1016/j.psyneuen.2017.07.238. Epub 2017 Jul 14.

  PMID: 28732265 BACKGROUND

• Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9;13:854. doi: 10.3389/fnins.2019.00854. eCollection 2019.

  PMID: 31447643 BACKGROUND

• Hossain MB, Kong Y, Posada-Quintero HF, Chon KH. Comparison of Electrodermal Activity from Multiple Body Locations Based on Standard EDA Indices' Quality and Robustness against Motion Artifact. Sensors (Basel). 2022 Apr 21;22(9):3177. doi: 10.3390/s22093177.

  PMID: 35590866 BACKGROUND

• Hirten RP, Lin KC, Whang J, Shahub S, Churcher NKM, Helmus D, Muthukumar S, Sands B, Prasad S. Longitudinal monitoring of IL-6 and CRP in inflammatory bowel disease using IBD-AWARE. Biosens Bioelectron X. 2024 Feb;16:100435. doi: 10.1016/j.biosx.2023.100435. Epub 2024 Jan 6.

  PMID: 38317723 BACKGROUND

• Fortenbaugh FC, DeGutis J, Esterman M. Recent theoretical, neural, and clinical advances in sustained attention research. Ann N Y Acad Sci. 2017 May;1396(1):70-91. doi: 10.1111/nyas.13318. Epub 2017 Mar 5.

  PMID: 28260249 BACKGROUND

• Esterman M, Noonan SK, Rosenberg M, Degutis J. In the zone or zoning out? Tracking behavioral and neural fluctuations during sustained attention. Cereb Cortex. 2013 Nov;23(11):2712-23. doi: 10.1093/cercor/bhs261. Epub 2012 Aug 31.

  PMID: 22941724 BACKGROUND

• Espinoza-Palavicino T, Mena-Chamorro P, Albayay J, Doussoulin A, Galvez-Garcia G. The use of transcutaneous Vagal Nerve Stimulation as an effective countermeasure for Simulator Adaptation Syndrome. Appl Ergon. 2023 Feb;107:103921. doi: 10.1016/j.apergo.2022.103921. Epub 2022 Oct 29.

  PMID: 36341733 BACKGROUND

• Eren OE, Filippopulos F, Sonmez K, Mohwald K, Straube A, Schoberl F. Non-invasive vagus nerve stimulation significantly improves quality of life in patients with persistent postural-perceptual dizziness. J Neurol. 2018 Oct;265(Suppl 1):63-69. doi: 10.1007/s00415-018-8894-8. Epub 2018 May 21.

  PMID: 29785522 BACKGROUND

• De Smet S, Ottaviani C, Verkuil B, Kappen M, Baeken C, Vanderhasselt MA. Effects of non-invasive vagus nerve stimulation on cognitive and autonomic correlates of perseverative cognition. Psychophysiology. 2023 Jun;60(6):e14250. doi: 10.1111/psyp.14250. Epub 2023 Jan 22.

  PMID: 36683127 BACKGROUND

• Colzato L, Beste C. A literature review on the neurophysiological underpinnings and cognitive effects of transcutaneous vagus nerve stimulation: challenges and future directions. J Neurophysiol. 2020 May 1;123(5):1739-1755. doi: 10.1152/jn.00057.2020. Epub 2020 Mar 25.

  PMID: 32208895 BACKGROUND

• Chuang CC, Ye JJ, Lin WC, Lee KT, Tai YT. Photoplethysmography variability as an alternative approach to obtain heart rate variability information in chronic pain patient. J Clin Monit Comput. 2015 Dec;29(6):801-6. doi: 10.1007/s10877-015-9669-8. Epub 2015 Feb 24.

  PMID: 25708672 BACKGROUND

• Cegarra J, Valery B, Avril E, Calmettes C, Navarro J. OpenMATB: A Multi-Attribute Task Battery promoting task customization, software extensibility and experiment replicability. Behav Res Methods. 2020 Oct;52(5):1980-1990. doi: 10.3758/s13428-020-01364-w.

  PMID: 32140999 BACKGROUND

• Broncel A, Bocian R, Klos-Wojtczak P, Kulbat-Warycha K, Konopacki J. Vagal nerve stimulation as a promising tool in the improvement of cognitive disorders. Brain Res Bull. 2020 Feb;155:37-47. doi: 10.1016/j.brainresbull.2019.11.011. Epub 2019 Nov 29.

  PMID: 31790720 BACKGROUND

• Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29.

  PMID: 21624874 BACKGROUND

• Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.

  PMID: 29361441 BACKGROUND

• Babic T, Browning KN. The role of vagal neurocircuits in the regulation of nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:38-47. doi: 10.1016/j.ejphar.2013.08.047. Epub 2013 Oct 31.

  PMID: 24184670 BACKGROUND

• Armstrong T, Olatunji BO. Eye tracking of attention in the affective disorders: a meta-analytic review and synthesis. Clin Psychol Rev. 2012 Dec;32(8):704-23. doi: 10.1016/j.cpr.2012.09.004. Epub 2012 Sep 20.

  PMID: 23059623 BACKGROUND

• Allen J. Photoplethysmography and its application in clinical physiological measurement. Physiol Meas. 2007 Mar;28(3):R1-39. doi: 10.1088/0967-3334/28/3/R01. Epub 2007 Feb 20.

  PMID: 17322588 BACKGROUND

Related Links

• OpenBCI Galea biosensing headset website
• Sparrow link device website

Study Officials

• Musa Mahmood, PhD

  OpenBCI

  PRINCIPAL INVESTIGATOR

• Zoe Steine-Hanson, PhD

  OpenBCI

  STUDY DIRECTOR

• Alejandro Covalin, PhD

  Spark Biomedical

  STUDY CHAIR

• Navid Khodaparast, PhD

  Spark Biomedical

  STUDY CHAIR

• Conor Russomanno, Masters

  OpenBCI

  STUDY CHAIR

Central Study Contacts

Musa Mahmood, PhD

CONTACT

347-692-8870; musa@openbci.com

Zoe Steine-Hanson, PhD

CONTACT

503-704-9780; zoe@openbci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, research assistants and study investigator will be blind. Only the study coordinator will be aware of research groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: April 30, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)