DHA For The Treatment of Pediatric Concussion Related to Sports Injury
Condition: Concussion; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Athletic Injuries
Intervention: Docosahexaenoic acid (DHA); Placebo
Intervention description: Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.; Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 14 Years
Maximum age: 18 Years
Healthy volunteers: No

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 considered a "ding" during a game or match, and the neurologic consequences of "playing
      through" or returning to play too soon has led to additional interest in and concern for
      pediatric athletes (18 or under) who experience sports-related concussions during game or
      practice play.

      Because it has only been in recent years that the full scope of damage done by repeated
      concussive episodes has come to light, very little research has been done on treatment of
      concussion in either adults or children. Brain injuries in children can be especially
      problematic, as the brain may continue to develop until the child reaches the age of 24 or
      older, so concussion during this time of development may be particularly damaging.

      Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and
      algae. DHA is known to improve development of the eyes and brain in young children. It is
      thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally
      and causes very few harmful side effects, it may be a useful compound in the treatment of
      pediatric concussion.

      This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric
      population. The investigators' primary aim is to determine acceptability of randomization for
      this compound as well as rate of enrollment given our clinical population. The investigators'
      secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects
      who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to
      play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated,
      clinical indicators of concussive recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or females age 14-18 inclusive

          2. Diagnosed with concussion due to sports-related injury. Concussion is defined as:

               1. Direct blow to the head, face, neck or a blow elsewhere on the body with an
                  "impulsive" force transmitted to the head.

               2. 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.

          3. Concussion within 4 days of enrollment

          4. Presenting for treatment to the Sports Medicine Center at Children's Medical Center

        Exclusion Criteria:

          1. Subjects not actively participating in an organized sport at time of enrollment

          2. Subjects who received a concussion from an event other than playing a sport (motor
             vehicle accident, fall, etc.)

          3. Subjects who participate in or received a concussion during participation in motorized
             sports (i.e., motorcross, dirt biking, jet skiing, etc.)

          4. Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture,
             intracranial hemorrhage, cerebral contusion, etc).

          5. Subjects with a prior diagnosed concussion in the previous 6 months.

          6. Pregnant women.

          7. Subjects sensitive to aspirin

          8. Subjects diagnosed with high blood pressure and currently being treated with blood
             pressure medications

          9. Subjects allergic to soy bean oil or corn oil.

         10. Subjects currently taking fish oil or DHA supplements.