Cognitive Abilities, Cognitive Performance, Performance, Stress
Conditions
Keywords
neurofeedback, cognitive performance, stress
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.
Detailed description
This study will test the efficacy and neurophysiologic mechanism of a novel EEG-guided binaural beat audio intervention for mitigating performance-related stress and enhancing cognition in musicians. The study is conducted at Texas Tech University (recruitment/screening/analysis) with neuroimaging and cognitive task data collection at the Texas Tech Neuroimaging Institute (TTNI). Participants complete a single in-person visit (\ 3 hours) including consent and eligibility screening, task training, pre-intervention VAS and fMRI scanning, randomization to intervention or sham, a 30-minute audio session, post-intervention fMRI scanning, and post-intervention VAS. The experimental audio intervention uses a proprietary algorithm with real-time EEG feedback from a single electrode over the left prefrontal cortex to dynamically adjust binaural beat frequencies during a 30-minute session delivered through headphones. The sham comparator uses non-binaural audio (music without interaural frequency differences) delivered identically. Participants and researchers conducting assessments are blinded to allocation.
Interventions
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.
OTHERNon-binaural audio intervention
30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.
Sponsors
Texas Tech University Health Sciences Center
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Double (Participant, Outcomes Assessor/Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session). | fMRI task-related activity in dlPFC, amygdala, hippocampus, and reactivity of mirror-neuron-related regions will be examined and compared between the groups. |
| 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. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session). | fMRI task-related activity in dlPFC, amygdala, hippocampus, and reactivity of mirror-neuron-related regions will be examined and compared between the groups. |
| 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. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session). | fMRI task-related activity in dlPFC, amygdala, and hippocampus during SSRT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported rating of overall well-being, 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). | 100 mm VAS, anchored at 0 ("Very poor well-being") and 100 ("Excellent well-being"). Higher scores = better well-being. |
| 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). | 100 mm VAS, anchored at 0 ("Not Stressed") and 100 ("Stressed"). Higher scores = greater stress. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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). |
| Self-reported level of confidence in performance 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). | 100 mm VAS, anchored at 0 ("Not confident at all") and 100 ("Extremely confident"). Higher scores = greater perceived confidence in performance. |
| 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). | 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). |
| Self-reported performance anxiety 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). | 100 mm VAS, anchored at 0 ("Not anxious at all") and 100 ("Extremely anxious"). Higher scores = greater perceived confidence in performance. |
| Self-reported performance on cognitive tasks, 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). | 100 mm VAS, anchored at 0 ("Worst Performance") and 100 ("Best Performance"). Higher scores = greater perceived confidence in performance. |
Countries
United States
Contacts
CONTACTChathurika S Dhanasekara, MD, PhD
CONTACTChanaka N Kahathuduwa, MD, PhD
Outcome results
None listed