NCT02519998

Brief Summary

The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

March 25, 2015

Last Update Submit

August 6, 2015

Conditions

Brain Concussion

Keywords

BiomarkersElectrocardiographyBalanceNeuropsychiatric assessmentCortisolCalcitonin-gene-related peptideElectroencephalographyOptical coherence tomographyVon Frey Testing

Outcome Measures

Primary Outcomes (1)

  • Medical history indicative of concussion

    Basic medical history demographics gathered during patient's regular clincal visit.

    Upon enrollment

Secondary Outcomes (34)

  • Neurocognitive Testing and Assessment Batteries

    1 year

  • Neurocognitive Testing and Assessment Batteries

    1 year

  • Neurocognitive Testing and Assessment Batteries

    1 year

  • Neurocognitive Testing and Assessment Batteries

    1 year

  • Neurocognitive Testing and Assessment Batteries

    1 year

  • +29 more secondary outcomes

Study Arms (2)

Concussed patients

The clinical focus of this study will be on concussed athletes, both children and adults, and we will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure.

Other: Concussion

Non-concussed patients

Cohort control. Primarily athletes who undergo routine pre-season baseline assessment

Interventions

ConcussionOTHER

Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)

Concussed patients

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.

You may qualify if:

  • All patients, 10 years of age or older with concussion being evaluated at the Jefferson Comprehensive Concussion Center in Philadelphia, PA, or by Jefferson Comprehensive Concussion Center physicians at other locations (including Rothman Institute sports medicine clinics in Bryn Mawr, PA, Marlton, NJ, Washington Township, NJ). The target population will be those with suspected concussions.

You may not qualify if:

  • Patients not presenting at the Jefferson Comprehensive Concussion Center or affiliated locations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson Comprehensive Concussion Center

Philadelphia, Pennsylvania, 19112, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Blood Saliva

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mijail Serruya, MD, PhD

    TJUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mijail Serruya, MD, PhD

CONTACT

267-463-2300

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

August 11, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

US(1)