An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
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|ClinicalTrials.gov Identifier: NCT02699346|
Recruitment Status : Unknown
Verified December 2016 by HeadSense Medical.
Recruitment status was: Recruiting
First Posted : March 4, 2016
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion Brain Injuries||Device: HS-1000 recording||Not Applicable|
Concussion diagnosis and assessment suffers from lack of a gold-standard measurement, leaving physicians to rely on physical and neurological examinations, neurocognitive/mental status testing, and balance examination, which can be time-consuming and influenced by subjective factors. In order to address this significant drawback, there is a need for novel modalities that diagnose and monitor concussion in a quick easy-to-use and non-invasive manner.
Based on our previous analysis of the physiological processes using acoustic signals that were collected and analyzed so far, our hypothesis is that the HS-1000 is capable of diagnosing and monitoring concussed patients, based on the acoustic raw data derived from the generated acoustic signal along with the analysis of the acoustic signals that derive from the physiological processes in the brain. These processes, e.g. cerebral blood-flow and the respiratory cycle, are impaired during changes in intracranial pressure (ICP) and are hypothesized to change as well once the patient is concussed.
Concussed athletes will be identified through routine visits at the Vanderbilt Sports Concussion Center. Controls will be identified among non-concussed athletes being seen at Vanderbilt Sports Medicine and will be offered participation.
After signing informed consent, both healthy subjects and patients will undergo screening assessments for this study. Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed.
Safety evaluation will include monitoring of adverse events throughout the study.
The study duration for each patient will be up to 1 hour. Healthy subjects will undergo two recordings approximately two weeks apart.
Post-concussion patients will have multiple sessions:
- Session #1 Baseline recording as soon as possible
- Session #2 48 hours after session #1
- Session #3 1 week after session #1
- Session #4 1 month after session #1
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Non-Randomized Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion With Clinical Evaluation|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: HS-1000 recording
Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed.
Device: HS-1000 recording
- To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects [ Time Frame: 20 minute recording session ]
- Determine the correlation between ICP measurements obtained from the HS-1000 device and the clinical findings from the modified Balance Error Score System (mBESS) and ImPACT scores in post-concussion patients. [ Time Frame: 20 minute recording session ]
- To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device. [ Time Frame: 20 minute recording sessin ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699346
|Contact: Tricia Kwiatkowski, M.D.||email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Timothy Lee, MHA, ATC 615-875-8722 firstname.lastname@example.org|
|Principal Investigator: Allen K Sills, MD|
|Principal Investigator:||Allen K Sills, MD||Vanderbilt University Medical Center|