The Role of Cerebral Oximetry in Pediatric Concussion Ass... | NCT02036333

Studies
The Role of Cerebral Oximetry in Pediatric Concussion Assessment

NCT02036333

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Feb 5, 2018Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Concussion, Brain
Concussion, Mild
Traumatic Brain Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Key Personnel Left Institution Prior to Study Completion

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Jan 13, 2014

First Submission Date that Met QC Criteria

Jan 13, 2014

First Posted Date

Jan 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2018

Last Update Posted Date

Feb 5, 2018Actual

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.		At presentation (Day 0)

Secondary Outcomes

Measure	Description	Time Frame
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.		At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

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:
1. 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)
2. Physical Signs (ie. loss of consciousness, unsteadiness)
3. 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).

EXCLUSION CRITERIA

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.
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

ID	Term
D001924	Brain Concussion
D000070642	Brain Injuries, Traumatic

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases