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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
All patients 12 to < 18 years of age being seen for, diagnosed with, and/or treated for traumatic brain injury (TBI) at the Akron Children's Hospital Sports Medicine Concussion Clinic are eligible for enrollment in this study.
The control group will consist of demographically comparable patients being treated at the Akron Children's Hospital Sports Medicine Center unrelated to head trauma. These non-brain injured study participants will receive the same ICP monitoring device measurements at their initial examination and follow-up visits as performed in concussed patients.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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.

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Who is running the clinical trial?

HeadSense MedicalLead Sponsor
11 Previous Clinical Trials
601 Total Patients Enrolled
Akron Children's HospitalOTHER
47 Previous Clinical Trials
5,008,244 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.
~10 spots leftby Mar 2025