EEG-Guided Binaural Beat Audio to Reduce Performance-Related Stress and Improve Cognition

NCT07407426 | Not Yet Recruiting

• 1 other identifier: IRB2025-681
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Performance-related stress can impair sustained attention, inhibitory control, and memory. This randomized, double-blinded, sham-controlled parallel-arm trial evaluates whether a 30-minute EEG-guided binaural beat audio intervention reduces subjective stress/performance anxiety and improves cognition, and whether it changes task-related brain reactivity measured by fMRI. The intervention uses real-time single-electrode EEG recorded over the left prefrontal cortex to dynamically adjust binaural beat frequencies to guide the brain toward a target state; the sham condition uses non-binaural music delivered through identical headphones. Adult music majors preparing for an upcoming concert will complete pre- and post-intervention fMRI sessions during cognitive/music tasks (Stop Signal Reaction Task, Music Reading Task, Music Memory Retrieval Task) and complete visual analog scales (VAS) assessing performance anxiety, stress, and related subjective states. The primary outcomes include fMRI task-related activity in stress-regulation regions (dlPFC, amygdala, hippocampus), behavioral inhibition indices from the stop-signal task, music memory retrieval accuracy, and VAS-reported stress/performance anxiety.

Conditions

Cognitive Performance; Performance; Stress; Cognitive Abilities

Keywords

neurofeedback; cognitive performance; stress

Outcome Measures

Primary Outcomes (3)

• Differences in fMRI blood oxygen level dependent (BOLD) responses of the brain in response to Stop Signals of a Stop Signal Reaction Time (SSRT) recorded following administration of each intervention and sham control.

  fMRI task-related activity in dlPFC, amygdala, and hippocampus during SSRT.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• Differences in fMRI blood oxygen level-dependent (BOLD) responses in the brain to images of the staff during the Music Reading Task (MRT), recorded following administration of each intervention and sham control.

  fMRI task-related activity in dlPFC, amygdala, hippocampus, and reactivity of mirror-neuron-related regions will be examined and compared between the groups.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• Differences in fMRI blood-oxygen-level-dependent (BOLD) responses in the brain to images of the staff during the Music Memory Retrieval Task (MMRT), recorded after administration of each intervention and the sham control.

  fMRI task-related activity in dlPFC, amygdala, hippocampus, and reactivity of mirror-neuron-related regions will be examined and compared between the groups.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

Secondary Outcomes (9)

• Stop Signal Reaction Time

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• Reaction Time on Music Memory Retrieval Task.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• Hit Rate of Music Memory Retrieval Task.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• False Alarm Rate of Music Memory Retrieval Task.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).

• Self-reported stress level, rated on a visual analogue scale.

  Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session).

Study Arms (2)

EEG-guided binaural beat audio

EXPERIMENTAL

30-minute session delivered via headphones; proprietary algorithm uses real-time single-electrode EEG from the left prefrontal cortex to dynamically adjust binaural beat frequencies.

Other: EEG-guided binaural beat audio

non-binaural audio

SHAM COMPARATOR

30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.

Other: Non-binaural audio intervention

Interventions

EEG-guided binaural beat audio OTHER

30-minute session delivered via headphones; proprietary algorithm uses real-time single-electrode EEG from the left prefrontal cortex to dynamically adjust binaural beat frequencies.

EEG-guided binaural beat audio

Non-binaural audio intervention OTHER

30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.

non-binaural audio

Eligibility Criteria

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

You may qualify if:

• Adults (18+ years) enrolled as undergraduate music majors at Texas Tech University
• Currently preparing for an upcoming concert performance within the next 3 months
• Able to read standard musical notation

You may not qualify if:

• Subjects with contraindications to undergo MRI after being screened by the TTNI safety screening sheet - specifically, Subjects with implanted devices that are not compatible with MRI including, but not limited to cardiac pacemakers, cardiac defibrillators, aneurysm clips, carotid artery vascular clamps, implanted nerve stimulators (neuron-stimulators also called TENS or wires), bone growth or bone fusion stimulators, cochlear implants, vagus nerve stimulators, filters for blood clots (Umbrella, Greenfield, bird's nest), embolization coils (e.g. Gianturco) in the brain, ocular implants, vascular stents, medication pumps, medication patches delivering medications, implanted limbs, ventricular shunts, metal joints, rods, plates, pins, screws, nails, or clips, penile implants, or contraceptives devices including IUDs, cervical pessaries and diaphragms Subjects who have undergone cataract surgery Subjects who have shrapnel or metal in the head, eyes or skin Subjects with a history of working with metal fragments ( or have had metal removed from eyes Subjects with gunshot wounds or BB gun injury Subjects with permanent metal body piercings or jewelry that cannot be removed Subjects who use hearing aids or have braces / permanent retainers that cannot be removed temporarily for the MRI scans Subjects with large tattoos in the head and neck area Subjects with claustrophobia Subjects who are currently pregnant or suspected to be pregnant
• Physical, medical, neurological or psychiatric impairments (including substance abuse)
• Current use of medications that could affect cognitive performance (including beta-blockers, stimulants, anxiolytics, antidepressants, or antipsychotics)
• History of head injury resulting in loss of consciousness/history of brain surgery
• History of diagnosed hearing impairment or use of hearing aids
• Current or past diagnosis of epilepsy or seizure disorders
• Unwillingness or inability to refrain from alcohol consumption 48 hours prior to the study visit
• Unwillingness or inability to refrain from caffeine consumption 12 hours prior to the study visit
• Current/past history of substance abuse
• Pregnancy or possibility of pregnancy
• Unwillingness or inability to follow written, on-screen, and verbal instructions given by the study team

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• Texas Tech University: collaborator

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79430, United States

Location

Central Study Contacts

Chathurika S Dhanasekara, MD, PhD

CONTACT

806 743 2378; samudani.dhanasekara@ttuhsc.edu

Chanaka N Kahathuduwa, MD, PhD

CONTACT

306 412 9974; chanaka.kahathuduwa@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Double (Participant, Outcomes Assessor/Investigator)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

US (1)