Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

Status: Unknown status
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
United States
Ohio
Akron Children's Hospital
Recruiting
Akron
Contact Information
Primary
Thomas Swanson
thomas@head-sense-med.com
Backup
Dana Hromyak, BS
dana@head-sense-med.com
216-526-8534
Time Frame
Start Date: May 2015
Completion Date: December 2017
Participants
Target number of participants: 100
Treatments
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.
Authors
Joseph Congeni, Thomas P Wolski Jr.
Related Therapeutic Areas
Sponsors
Leads: HeadSense Medical
Collaborators: Akron Children's Hospital

This content was sourced from clinicaltrials.gov

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