Status:
COMPLETED
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Children's Medical Center Dallas
Texas Scottish Rite Hospital for Children
Conditions:
Concussion
Mild Traumatic Brain Injury
Eligibility:
All Genders
14-18 years
Phase:
PHASE1
Brief Summary
In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considere...
Detailed Description
This is a double-blind, randomized, placebo-controlled feasibility trial of DHA for the treatment of pediatric concussion related to sports-injury. The definition used for concussion is from the Conse...
Eligibility Criteria
Inclusion
- Male or females age 14-18 inclusive
- Diagnosed with concussion due to sports-related injury. Concussion is defined as:
- Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.
- Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:
- i. Symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog and/or emotional symptoms (eg, lability).
- ii. Physical signs (eg, loss of consciousness, amnesia).
- iii. Behavioral changes (eg, irritability).
- iv. Cognitive impairment (eg, slowed reaction times).
- v. Sleep disturbance (eg, drowsiness). c) No abnormality on standard structural neuroimaging studies, if such neuroimaging studies are completed for a clinically-indicated reason. Note: neuroimaging is not a part of this study protocol. Study participants will not undergo neuroimaging as part of this study.
- Concussion within 4 days of enrollment
- Presenting for treatment to the Sports Medicine Center at Children's Medical Center
Exclusion
- Subjects not actively participating in an organized sport at time of enrollment
- Subjects who received a concussion from an event other than playing a sport (motor vehicle accident, fall, etc.)
- Subjects who participate in or received a concussion during participation in motorized sports (i.e., motorcross, dirt biking, jet skiing, etc.)
- Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture, intracranial hemorrhage, cerebral contusion, etc).
- Subjects with a prior diagnosed concussion in the previous 6 months.
- Pregnant women.
- Subjects sensitive to aspirin
- Subjects diagnosed with high blood pressure and currently being treated with blood pressure medications
- Subjects allergic to soy bean oil or corn oil.
- Subjects currently taking fish oil or DHA supplements.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01903525
Start Date
September 1 2013
End Date
August 1 2017
Last Update
January 11 2021
Active Locations (1)
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1
Sports Medicine at Texas Scottish Rite Hospital for Children
Plano, Texas, United States, 75093