RECRUITING

Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

CAMSAN: Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation

Quick Facts

Study Start:2025-02-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06782360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy human subjects between the ages of 18 and 55
  2. * Normal color vision and near visual acuity of 20/30 without correction.
  3. * Participant is right-hand dominant
  4. * Proficient in the English language
  5. * Ability to understand the explanations and instructions given by the study personnel
  1. * Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
  2. * Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
  3. * Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
  4. * Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
  5. * 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.
  6. * Participant has abnormal ear anatomy, ear infection present, or ear piercing that could interfere with stimulation
  7. * Participant has a recent history of epileptic seizures; including photosensitive epilepsy
  8. * Participant has a recent history of neurologic diseases or traumatic brain injury
  9. * Participant has presence of implanted medical devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
  10. * Females who are pregnant or lactating
  11. * 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
  12. * Sensitivity to bright screens or virtual reality displays
  13. * Recent history of neurological and psychiatric disease/disorder

Contacts and Locations

Study Contact

Musa Mahmood, PhD
CONTACT
347-692-8870
musa@openbci.com
Zoe Steine-Hanson, PhD
CONTACT
503-704-9780
zoe@openbci.com

Principal Investigator

Musa Mahmood, PhD
PRINCIPAL_INVESTIGATOR
OpenBCI
Zoe Steine-Hanson, PhD
STUDY_DIRECTOR
OpenBCI
Alejandro Covalin, PhD
STUDY_CHAIR
Spark Biomedical
Navid Khodaparast, PhD
STUDY_CHAIR
Spark Biomedical
Conor Russomanno, Masters
STUDY_CHAIR
OpenBCI

Study Locations (Sites)

OpenBCI
Brooklyn, New York, 11222
United States

Collaborators and Investigators

Sponsor: OpenBCI

  • Musa Mahmood, PhD, PRINCIPAL_INVESTIGATOR, OpenBCI
  • Zoe Steine-Hanson, PhD, STUDY_DIRECTOR, OpenBCI
  • Alejandro Covalin, PhD, STUDY_CHAIR, Spark Biomedical
  • Navid Khodaparast, PhD, STUDY_CHAIR, Spark Biomedical
  • Conor Russomanno, Masters, STUDY_CHAIR, OpenBCI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • cognitive performance
  • neurostimulation
  • stress
  • attention
  • cybersickness
  • biosensing

Additional Relevant MeSH Terms

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