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Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

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ClinicalTrials.gov Identifier: NCT02699359
Recruitment Status : Unknown
Verified December 2016 by HeadSense Medical.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Akron Children's Hospital
Information provided by (Responsible Party):
HeadSense Medical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Brain Concussion Brain Injuries Device: HS-1000 recording Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Study Start Date : May 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of recordings that correlate to concussion diagnosis using current standards [ Time Frame: 16 minute recording period ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02699359


Contacts
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Contact: Thomas Swanson thomas@head-sense-med.com
Contact: Dana Hromyak, BS 216-526-8534 dana@head-sense-med.com

Locations
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United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Heather Anthony, RN    330-543-0731    hanthony@chmca.org   
Principal Investigator: Joseph Congeni, MD         
Sub-Investigator: Thomas P Wolski Jr., DO         
Sponsors and Collaborators
HeadSense Medical
Akron Children's Hospital
Investigators
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Principal Investigator: Joseph Congeni, MD Akron Children's Hospital
More Information
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Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02699359    
Other Study ID Numbers: HS-022
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by HeadSense Medical:
concussion
mild traumatic brain injuries
Additional relevant MeSH terms:
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Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
 Trauma, Nervous System
Wounds and Injuries
Brain Injuries, Traumatic
Head Injuries, Closed
Wounds, Nonpenetrating