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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Double (Participant, Outcomes Assessor/Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EEG-guided binaural beat audio
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.
干预措施: EEG-guided binaural beat audio (Other)
non-binaural audio
30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.
干预措施: Non-binaural audio intervention (Other)
结局指标
主要结局
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.
时间窗: 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.
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.
时间窗: 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.
时间窗: 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.
次要结局
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
研究者
Samudani Dhanasekara
Assistant Professor
Texas Tech University Health Sciences Center