Recruiting

Binaural Beats

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT07407426

Conditions

Cognitive Abilities

Performance

Stress

Cognitive Performance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

EEG-guided binaural beat audio

Non-binaural audio intervention

Study Details

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.

Conditions

Cognitive Abilities

Performance

Stress

Cognitive Performance

Study ID

NCT07407426

Start date

Apr 7, 2026

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: non-binaural audio

30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.

Interventions

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.

Non-binaural audio intervention

30-minute session of music without frequency differences between ears (non-binaural), delivered via identical headphones; blinding maintained.

Primary outcome measure

  • 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. [ 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). ]
  • 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. [ 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). ]
  • 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. [ 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). ]

Central Contacts and Locations

Central contacts

Chathurika S Dhanasekara, MD, PhD

806 743 2378samudani.dhanasekara@ttuhsc.edu

Chanaka N Kahathuduwa, MD, PhD

306 412 9974chanaka.kahathuduwa@ttuhsc.edu

Locations

Texas Tech University

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Chathurika S Dhanasekara, MD, PhD

806 743 2378Samudani.Dhanasekara@ttuhsc.edu

Chanaka N Kahathuduwa, MD, PhD

806 412 9974Chanaka.Kahathuduwa@ttuhsc.edu

Principal Investigator:

Chathurika S Dhanasekara, MD, PhD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Aug 24, 2026

Last verified

Feb, 2026

Keywords

  • neurofeedback
  • cognitive performance
  • stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-08-24.