NCT02699359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 30, 2019

Status Verified

December 1, 2016

Enrollment Period

2.1 years

First QC Date

February 22, 2016

Last Update Submit

October 29, 2019

Conditions

Brain ConcussionBrain Injuries

Keywords

concussionmild traumatic brain injuries

Outcome Measures

Primary Outcomes (1)

  • Number of recordings that correlate to concussion diagnosis using current standards

    16 minute recording period

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

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

Interventions

HS-1000 recordingDEVICE
HS-1000 recording

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

MeSH Terms

Conditions

Brain ConcussionBrain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Joseph Congeni, MD

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Swanson

CONTACT

thomas@head-sense-med.com

Dana Hromyak, BS

CONTACT

216-526-8534dana@head-sense-med.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 4, 2016

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

October 30, 2019

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)