Concussion, BrainNCT02036333
The Role of Cerebral Oximetry in Pediatric Concussion Assessment
An observational study of Concussion, Brain and Concussion, Mild, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Concussion, Mild, Traumatic Brain Injury
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 30 Jun 2015
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This pilot study will employ a prospective cohort study design. Children aged 10-18 years will be recruited within the Johns Hopkins Hospital Pediatric Emergency Department (JHH PED) to participate in this study. All children must be conversant in English.
Who may be able to join
- All Participants
- Age 10-18 years at time of visit
- Concussion Group
- Present to JHH PED within the first 24 hours following trauma.
- Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:
- Symptoms (ie. headache, neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitive to light, sensitivity to noise, feeling slowed down, feeling in a fog, difficulty concentrating, difficulty remembering, fatigue, confusion, drowsiness, more emotional, irritability, sadness, nervous)
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- Physical Signs (ie. loss of consciousness, unsteadiness)
- Impaired brain function (ie. confusion)
- Glasgow Coma Score of 13-15 upon arrival to JHH PED.
- Loss of consciousness of less than 15 minutes (if applicable).
- No structural intracranial injuries identified on neuroimaging (if completed).
Who cannot join
- All Participants
- History of prior concussion or traumatic brain injury within preceding 6 weeks.
- History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)
- Presence of intracranial hardware.
- Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.
- Inability to stand secondary to lower extremity disease or trauma, which is required for completion of SCAT2.
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- Inability to complete SCAT2 questionnaire secondary to developmental delay.
- Child in foster care or legal guardian not available.
- Participant known to be pregnant, which alters total body blood flow and likely affects regional cerebral oxygen saturation.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Pediatric Emergency Medicine
Baltimore, Maryland, 21224
About this study
The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.
- Conditions
- Concussion, Brain, Concussion, Mild, Traumatic Brain Injury
- Keywords
- near infrared spectroscopy, pediatrics
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Concussion Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.
Measured: At presentation (Day 0)
Secondary outcomes (2)
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.
Measured: At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.
Measured: At presentation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Why it stopped: Key Personnel Left Institution Prior to Study Completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Jennifer Anders, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036333
- Sponsor's protocol ID
- NA_00078909
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cerebral Oximetry in Pediatric Concussion Assessment
- ClinicalTrials.gov ID
- NCT02036333
- Acronym / sponsor ID
- NA_00078909
- Conditions
- Concussion, Brain, Concussion, Mild, Traumatic Brain Injury
- Keywords
- near infrared spectroscopy, pediatrics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Key Personnel Left Institution Prior to Study Completion
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 15 Jan 2014 (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 purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This pilot study will employ a prospective cohort study design. Children aged 10-18 years will be recruited within the Johns Hopkins Hospital Pediatric Emergency Department (JHH PED) to participate in this study. All children must be conversant in English.
Key inclusion criteria (11 listed)
- All Participants
- Age 10-18 years at time of visit
- Concussion Group
- Present to JHH PED within the first 24 hours following trauma.
- Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:
Key exclusion criteria (10 listed)
- All Participants
- History of prior concussion or traumatic brain injury within preceding 6 weeks.
- History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)
- Presence of intracranial hardware.
- Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.
Time frame: At presentation (Day 0)
2 secondary outcomes
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.
Time frame: At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.
Time frame: At presentation (Day 0)
Results and safety
The study was stopped early (reason given: Key Personnel Left Institution Prior to Study Completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Jennifer Anders, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Concussion, Mild, run by Johns Hopkins University 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Feb 2018. 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?
The study was stopped early (reason given: Key Personnel Left Institution Prior to Study Completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls. (time frame: At presentation (Day 0)). 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 5 Feb 2018.