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Device

HS-1000 recording for Traumatic Brain Injury

N/A
Waitlist Available
Led By Joseph Congeni, 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 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 minute recording period
Awards & highlights

Study Summary

The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any, that may exist between concussion, timing of the concussion (e.g. acute, resolving, resolved) and ICP is unknown. The new HS-1000 non-invasive device may provide insight into assessment of possible ICP changes following concussion in children.

Eligible Conditions
  • Traumatic Brain Injury
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 minute recording period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 minute recording period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of recordings that correlate to concussion diagnosis using current standards

Trial Design

1Treatment groups
Experimental Treatment
Group I: HS-1000 recordingExperimental Treatment1 Intervention
Study participants will receive HS-1000 ICP readings for a continuous 16 minute interval in a 30 degree supine position. Recordings will be obtained in one session. When possible, these recordings will be obtained at their initial examination and all follow-up visits. Sports Medicine staff will coordinate the HS-1000 device earplug insertion and recordings so as not to interfere with, nor marginally delay the patient's normal, routine clinical evaluation.

Find a Location

Who is running the clinical trial?

HeadSense MedicalLead Sponsor
11 Previous Clinical Trials
601 Total Patients Enrolled
Akron Children's HospitalOTHER
48 Previous Clinical Trials
5,008,494 Total Patients Enrolled
Joseph Congeni, MDPrincipal InvestigatorAkron Children's Hospital
1 Previous Clinical Trials
174 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
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
2015. "Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02699359.
All > Concussion
~10 spots leftby May 2025
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