Texas Tech University
Lubbock, Texas, 79430, United States
Location contact
Chanaka N Kahathuduwa, MD, PhD
CONTACT
Chathurika S Dhanasekara, MD, PhD
CONTACT
Chathurika S Dhanasekara, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07407426
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Lubbock, Texas, 79430, United States
Chanaka N Kahathuduwa, MD, PhD
CONTACT
Chathurika S Dhanasekara, MD, PhD
CONTACT
Chathurika S Dhanasekara, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.
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).
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).
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).
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).
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).
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).
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).
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 40 minutes after completion of session).
100 mm VAS, anchored at 0 ("Not Stressed") and 100 ("Stressed"). Higher scores = greater stress.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Chanaka N Kahathuduwa, MD, PhD
CONTACT
Chathurika S Dhanasekara, MD, PhD
CONTACT
Texas Tech University Health Sciences Center
Other
Effects of EEG-guided Binaural Beat Audio Intervention on Brain Reactivity Associated With Performance-related Stress and Cognition Among Professional Musicians: A Randomized, Double-blinded, Sham-controlled Functional Neuroimaging Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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