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| Name | Class |
|---|---|
| Texas Tech University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| non-binaural audio | Sham Comparator | 30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 30 minutes after completion of session). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University | Lubbock | Texas | 79430 | United States |
De-identified individual participant data may be shared with qualified researchers upon a reasonable request and after obtaining institutional approval, as the study is based on a proprietary algorithm owned by Texas Tech University.
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Double (Participant, Outcomes Assessor/Investigator)
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| Non-binaural audio intervention | Other | 30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained. |
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| 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. | 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. | 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). | 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. | 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). | 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. | 100 mm VAS, anchored at 0 ("Not Stressed") and 100 ("Stressed"). Higher scores = greater stress. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session). |
| Self-reported level of confidence in performance on a visual analogue scale. | 100 mm VAS, anchored at 0 ("Not confident at all") and 100 ("Extremely confident"). Higher scores = greater perceived confidence in performance. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session). |
| Self-reported performance anxiety level, rated on a visual analogue scale. | 100 mm VAS, anchored at 0 ("Not anxious at all") and 100 ("Extremely anxious"). Higher scores = greater perceived confidence in performance. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session). |
| Self-reported performance on cognitive tasks, rated on a visual analogue scale. | 100 mm VAS, anchored at 0 ("Worst Performance") and 100 ("Best Performance"). Higher scores = greater perceived confidence in performance. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session). |
| Self-reported rating of overall well-being, rated on a visual analogue scale. | 100 mm VAS, anchored at 0 ("Very poor well-being") and 100 ("Excellent well-being"). Higher scores = better well-being. | Baseline (immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 40 minutes after completion of session). |