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HS-1000 recording for Concussion

N/A
Waitlist Available
Led By Allen K Sills, MD
Research Sponsored by HeadSense Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minute recording sessin
Awards & highlights

Study Summary

The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement. The device is based on advanced signal analysis algorithms that analyze a very low frequency acoustic signal (within the audible range) generated by the device. The acoustic signal is transmitted using a small transmitter, placed in the participant's ear, and picked by an acoustic sensor placed in the other ear.

Eligible Conditions
  • Concussion
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minute recording sessin
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minute recording sessin for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects
Secondary outcome measures
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HS-1000 recordingExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

HeadSense MedicalLead Sponsor
11 Previous Clinical Trials
601 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
858 Previous Clinical Trials
672,193 Total Patients Enrolled
Allen K Sills, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
43 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
2015. "An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02699346.
All > Concussion
~10 spots leftby May 2025
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