Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

October 29, 2019 updated by: HeadSense Medical
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Unlike fractures, concussion can be difficult to recognize and diagnose, given lack of specific diagnostic tests or clinical findings. Current diagnostic recommendations include a multi-factorial approach involving symptom inventory, baseline and post-injury neuropsychological assessment, and balance testing.

Lacking from this paradigm is a truly objective measure of physiological changes associated with concussion. In addition, post-concussion symptoms are unique to each individual and vary in occurrence, degree, and severity. For these reasons, a clinical diagnosis of concussion should be made by a healthcare provider familiar with the athlete and knowledgeable in concussion symptom recognition and evaluation.

This study aims to determine ICP measurements derived from the HS-1000 non-invasive device in children and adolescents seen in the Akron Children's Hospital Sports Medicine Clinic for concussion (anytime during their care) compared to ICP values obtained in age and gender matched Akron Children's Hospital Sports Medicine Clinic patients with no history of head injury.

Patients with a history and/or symptoms of head trauma cared for in the Akron Children's Hospital Sports Medicine Clinic will be invited to participate in this study. 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Congeni, MD
        • Sub-Investigator:
          • Thomas P Wolski Jr., DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Receiving therapy for otitis media
  • Subject with bony abnormality of the skull secondary to previous fracture or other cause that may impede HeadSense device
  • Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
  • For females of childbearing potential: pregnancy (positive pregnancy test)
  • Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
  • Any condition that may jeopardize study participation or interpretation of study results (e.g., abnormal clinical finding), or may impede the ability to obtain informed consent (e.g., developmental delay of patient or caretaker)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS-1000 recording
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.
Device: HS-1000 recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of recordings that correlate to concussion diagnosis using current standards
Time Frame: 16 minute recording period
16 minute recording period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HeadSense Medical

Collaborators

Akron Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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