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Sound therapy with binaural beats to improve wakefulness in patients with reduced consciousness after a traumatic injury.

Auditory Stimulation with Binaural Beats to Improve Wakefulness in Traumatic Brain Injury Patients with Disorders of Consciousness A pilot study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113224
Enrollment
32
Registered
2026-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S062- Diffuse traumatic brain injury Health Condition 2: S064- Epidural hemorrhage Health Condition 3: S063- Focal traumatic brain injury Health Condition 4: S068- Other specified intracranial injuries Health Condition 5: S061- Traumatic cerebral edema Health Condition 6: S066- Traumatic subarachnoid hemorrhage Health Condition 7: S065- Traumatic subdural hemorrhage Health Condition 8: S069- Unspecified intracranial injury

Interventions

Intervention1: Auditory stimulation with binaural beats: Baseline assessment will be done using GCS, CRS R, WHIM, DRS scores and 1 hour EEG telemetry. The intervention group will be given alpha frequ

Sponsors

Fluid Research Grant, CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Traumatic Brain injury patients with Disorders of consciousness in Vegetative state, minimally conscious state i.e. RLA stages 2 to 3 following severe traumatic brain injury and as per CRS Revised score 2. Patients admitted for rehabilitation 3. Ages 18 to 70 years 4. 2 weeks to 6 months after injury 5. Normal BAER 6. Post cranioplasty if decompressive craniectomy is done 7. Medically and neurologically stable.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled seizure episodes within one month duration 2. Prior diagnosis of epilepsy 3. Post craniectomy defect 4. Medical illnesses 5. History of cardiac arrythmias or pacemaker 6. History of hearing impairment

Design outcomes

Primary

MeasureTime frame
To evaluate whether patients with traumatic brain injury in disorders of consciousness (RLA Levels II III) in the subacute and chronic phases show superior improvements in consciousness when receiving 30 sessions of auditory stimulation with sustained alpha frequency binaural beats combined with a conventional coma stimulation programme, compared with those receiving 30 sessions of music based sham intervention plus coma stimulation, as assessed using the Glasgow Coma Scale (GCS), Coma Recovery Scale Revised (CRS-R), Wessex Head Injury Matrix (WHIM) and Disability Rating Scale (DRS).Timepoint: At baseline and end of 15 days.—

Secondary

MeasureTime frame
To evaluate changes in background cerebral activity using EEG, before and after auditory stimulation with binaural beats. This will be performed using a qualitative assessment of EEG background activity, and graded using the Synek EEG grading system, which classifies EEG patterns based on predominant background frequency and degree of slowing.Timepoint: Baseline and end of 15 days.—

Countries

India

Contacts

Public ContactDr Raji Thomas

CMC Vellore

rajithomas@cmcvellore.ac.in04162282158

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026