Brain ConcussionNCT02699359
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
A study testing HS-1000 recording in people with Brain Concussion and Brain Injuries, run by HeadSense Medical at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Brain Injuries
- What is being tested?
- HS-1000 recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Thomas Swanson contact
United States1 site, 1 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Heather Anthony, RN, 330-543-0731, hanthony@chmca.org
Joseph Congeni, MD
About this study
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.
Read the 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.
- Conditions
- Brain Concussion, Brain Injuries
- Being tested
- HS-1000 recording
- Keywords
- concussion, mild traumatic brain injuries
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000 recordingDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HS-1000 recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recordings that correlate to concussion diagnosis using current standards
Measured: 16 minute recording period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akron Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph Congeni, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699359
- Sponsor's protocol ID
- HS-022
- Status last verified
- Dec 2016
- First submitted
- 22 Feb 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
- ClinicalTrials.gov ID
- NCT02699359
- Acronym / sponsor ID
- HS-022
- Conditions
- Brain Concussion, Brain Injuries
- Keywords
- concussion, mild traumatic brain injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Akron Children's Hospital
- Study start
- May 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-1000 recording | Experimental | Device: HS-1000 recordingStudy 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-1000 recording | Device | HS-1000 recording |
Primary outcome
Number of recordings that correlate to concussion diagnosis using current standards
Time frame: 16 minute recording period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Swanson contact
Joseph Congeni, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 recording in people with Brain Concussion and Brain Injuries, run by HeadSense Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Swanson (thomas@head-sense-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recordings that correlate to concussion diagnosis using current standards (time frame: 16 minute recording period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.