EEG-Guided Binaural Beat Audio to Reduce Performance-Related Stress and Improve Cognition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Tech University Health Sciences Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EEG-guided binaural beat audio
Other intervention30-minute session delivered via headphones; proprietary algorithm uses real-time single-electrode EEG from the left prefrontal cortex to dynamically adjust binaural beat frequencies.
Non-binaural audio intervention
Other intervention30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: EEG-guided binaural beat audioExperimental treatment 1 intervention
Group B: non-binaural audioSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).2
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.
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).3
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.
Time frame
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
1
Stop Signal Reaction Time
Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, computed using the horse-race model and drift-diffusion theory. Lower values indicate better inhibitory control.
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).2
Reaction Time on Music Memory Retrieval Task.
Mean response latency (seconds) during the Music Memory Retrieval Task recognition phase. Lower values indicate faster information retrieval and decision speed without implying a speed-accuracy trade-off. The unit of measurement is in seconds.
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).3
Hit Rate of Music Memory Retrieval Task.
Subjects will be presented with images of staff. Proportion of targets correctly identified as "seen." Range 0-1; higher values indicate better recognition sensitivity. The unit of measurement is in proportion (0-1).
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).4
False Alarm Rate of Music Memory Retrieval Task.
Subjects will be presented with images of staff. Proportion of non-targets incorrectly endorsed as "seen." Range 0-1; lower values indicate better discrimination (fewer false positives). The unit of measurement is in proportion (0-1).
Time frame
Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas Tech University Health Sciences Center
Lead sponsor
Texas Tech University
Collaborator
Source ClinicalTrials.gov