Collecting brain monitoring data using non-invasive ultrasound
NOninVasive Intracranial PrEssure from Transcranial DoppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
This study is collecting brain monitoring data from patients with brain injuries using ultrasound to help improve future treatments and understanding of their conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Davis, California and 3 other locations) |
| Trial ID | NCT04548596 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a comprehensive database of multimodality monitoring signals from brain-injured patients using Transcranial Doppler (TCD) ultrasound. Conducted in neurocritical care units at several prominent medical centers, the study will record cerebral blood flow velocity signals from patients with conditions such as traumatic brain injury and ischemic stroke. The data collection will occur in four scenarios, with each recording lasting up to 60 minutes, focusing on gathering high-resolution physiological signals to support future algorithm development and validation. This project is not hypothesis-driven but seeks to enhance understanding of brain monitoring.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with an intracranial pressure monitoring device.
Not a fit: Patients with unstable medical conditions or those who cannot safely undergo the TCD procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring and management of brain injuries, leading to better patient outcomes.
How similar studies have performed: While this approach is observational and not hypothesis-driven, similar studies utilizing non-invasive monitoring techniques have shown promise in enhancing patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female subjects 18 years of age and older 2. Subjects who have an ICP Monitoring device Exclusion Criteria: 1. Unstable medical illness such as recordings might interfere with medical care. 2. Subjects that don't have a viable temporal window to insonate the MCA. 3. Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.
Where this trial is running
Davis, California and 3 other locations
- UC Davis — Davis, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Withdrawn)
Study contacts
- Principal investigator: Xiao Hu — Emory University
- Study coordinator: Xiao Hu, PhD
- Email: xiao.hu@emory.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.