Auditory Stimuli for Coma

Recruiting at 1 trial location

Overseen By Ayham Alkhachroum, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Under 18, Pregnant, Cardiac arrest, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether music and language can help unconscious patients with acute brain injuries regain consciousness. Researchers will use an EEG (a test that measures brain activity) to observe how these patients' brains respond to sounds. The study also includes healthy volunteers to compare brain responses. It seeks participants who are in the ICU due to a severe brain injury and are currently unconscious.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance recovery methods for brain injury patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electroencephalogram (EEG) is safe for monitoring brain response?

Research has shown that using an electroencephalogram (EEG) to measure brain activity is safe and well-tolerated by both healthy individuals and those with brain injuries. Studies have found that EEG can detect brain responses even in unresponsive patients, allowing for monitoring without harm.

EEG is a noninvasive procedure, meaning it doesn't involve surgery or entering the body, which reduces the risk of complications. Research conducted in hospitals has indicated that EEG does not cause serious side effects. It is a common tool used to observe brain function in many conditions.

Overall, EEG is considered safe due to its widespread use and the lack of reported safety issues in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electroencephalogram (EEG) for acute brain injury recovery because it offers a non-invasive way to monitor brain activity in real-time. Unlike traditional imaging methods like CT or MRI scans, which only provide static images, EEG tracks the brain's response to auditory and visual stimuli as they happen. This dynamic insight can help pinpoint specific areas of the brain that are affected, potentially leading to more personalized treatment plans. Furthermore, by including healthy volunteers as a control group, researchers can better understand the normal brain responses to these stimuli, providing a clearer picture of the deviations caused by acute brain injuries.

What evidence suggests that using EEG is effective for assessing outcomes in acute brain injury patients?

Research has shown that EEG, a test that tracks brain activity, can help predict recovery in patients with severe brain injuries. In this trial, researchers will study acute brain injury patients using EEG to monitor their brain response to auditory and visual stimuli. Studies indicate that EEG can reveal important patterns in brain activity, aiding doctors in understanding a patient's condition and potential outcomes. For example, certain EEG features can provide clues about a patient's chances of waking up and their overall recovery. These findings suggest that EEG could be a useful tool in assessing and potentially improving recovery for brain injury patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Ayham Alkhachroum, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

For TBI Participants

Unconscious with Glasgow Coma Scale (GCS) <8 on presentation and unable to follow bedside commands.

A negative COVID-19 test on arrival

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EEG Monitoring

Participants undergo electroencephalogram (EEG) to monitor brain response to auditory and visual stimuli

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after EEG monitoring

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Electroencephalogram (EEG)

How Is the Trial Designed?

Group I: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

Group II: Acute Brain Injury Patients Experimental Treatment 1 Intervention

Acute brain injury (ABI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9353690/

Detecting Seizures and Epileptiform Abnormalities in Acute ... It is clear that EEG findings, both ictal and interictal, play important roles in the triaging, management, and prognosis of patients with ABI.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0883944124003484

Indications, results and consequences of ... Recent studies have shown promising results of EEG recordings with reactivity testing for prognostication in patients with severe acute brain injury and ...

3. link.springer.com link.springer.com/article/10.1007/s00134-025-08121-7

Update on acute brain injury | Intensive Care Medicine Cerebral biomarkers play a significant role in predicting outcomes after acute brain injury ... outcomes—an analysis of CENTER-ABI data. Intensive ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000212375

Predictive Value of Early Quantitative EEG Features in ... qEEG features, notably beta/delta power and total-power, have satisfactory predictive value of ICU-TBI outcome when added to clinical features.

5. academic.oup.com academic.oup.com/braincomms/article/3/2/fcab017/6166646

prognostic value of resting-state EEG in acute post-traumatic ... While we do not have sufficient 12-month outcome data for our cohort, the evidence that the value of acute resting-state EEG markers reduces ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10008537/

Electroencephalogram in the intensive care unit ESz are common in critically ill pediatric and adult patients, with prevalence rates ranging from 3 to 47% across a variety of conditions including traumatic ...

7. openneurologyjournal.com openneurologyjournal.com/VOLUME/16/ELOCATOR/e1874205X2206100/

Electroencephalography Findings in Traumatic Brain Injury Electroencephalography was the first clinical neurodiagnostic assessment to reveal abnormal brain function after a head injury.

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1812757

Detection of Brain Activation in Unresponsive Patients with ... Brain activation in response to spoken motor commands can be detected by electroencephalography (EEG) in clinically unresponsive patients.

9. nature.com nature.com/articles/s43856-023-00344-3

Noninvasive and reliable automated detection of spreading ... The dataset for testing our algorithm contains 700 total SDs in 12 severe TBI patients who underwent decompressive hemicraniectomy (DHC), ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2213158223000396

Early EEG monitoring predicts clinical outcome in patients ... We assess the ability of early continuous EEG monitoring at the intensive care unit (ICU) in patients with traumatic brain injury (TBI) to predict long term ...