Docosahexaenoic acid (DHA) for the treatment of pediatric concussion related to sports injury

Study ID
STU 042012-055

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Texas Scottish Rite Hospital for Children

Contact
Naureen Tareen
214-456-1719
naureen.tareen@childrens.com

Principal Investigator
Shane Miller

Summary

This is a double-blind, randomized, placebo-controlled feasibility trial of DHa for treatment of pediatric concussion related to sports-injury. our definition for concussion is from the Consensus Statement on Concussion in Sport: the 3rd international Conference on Concussion in Sport (Br J Sports Med 2009;43:Suppl 1 i76-i84): [Quote]Concussion is defined as a complex pathophysiological process affecting the brain, induced by traumatic biomechanical forces[Quote] and without abnormalities on standard structural neuroimaging studies (i.e., CT or MRi). it is a clinical diagnosis made by the physician based on mechanism of injury and clinical signs and symptoms. Subjects will be randomized in a 1:1 fashion.
Martek Biosciences provides an algae-based DHa compound which minimizes the side effects of [Quote]fishiness[Quote] in both flavor and [Quote]fish burps.[Quote] DHa and identical placebo will be provided by Martek Biosciences. The DHaSCo capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHa per capsule. The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil.
Subjects will be randomized to 2 g of DHa or matched placebo for 12 weeks. in order to achieve this dose of DHa, subjects will receive 2 950 mg capsules twice a day. Subjects who cannot tolerate the divided dose of 2 g per day will be discontinued from the study.
The primary outcomes of this feasibility trial are to assess patient acceptance of randomization, the rate of enrollment, and protocol adherence of study participants. We anticipate the results from this study will inform a larger randomized trial of DHa for the treatment of pediatric sports concussion. Secondary outcomes are time to clearance to return to play (in days) and improvement in balance, as assessed by the Balance error Scoring System (BeSS) which is a component of the Sport Concussion assessment Tool 3 (SCaT-3).
Time to clearance to return to play was chosen as a clinically significant measurement for medical professionals in the sports medicine field. The investigators will determine clearance for return to full competitive game play (Stage 6 of graduated return to play protocol) according to Consensus Statement guidelines and following the law in Texas, House Bill 2038. Criteria for return to play include complete clinical recovery from the concussion including returning to baseline symptoms, exam and neurocognitive function and successful completion of a gradual return to play progression. The BeSS was chosen because it is a relatively simple assessment that has been noted by the investigators to be a good predictor of neurological recovery.
additionally, the SCaT 3 and immediate Post Concussion assessment and Cognitive Testing (imPaCT) computerized neurocognitive testing programs will be used to evaluate recovery. The SCaT-3 is a standardized method of evaluating injured athletes (age 10 and older) for concussion. The imPaCT program is a computerized exam that helps to quantify the degree of symptom, injury, or dysfunction that occurs after a sports related concussion.
Finally, side effects will be collected at every visit in order to track the rate and severity of side effects.
We plan to enroll 40 subjects for this study; 20 subjects to be treated with DHa and 20 subjects to be treated with placebo. We anticipate screening 80 subjects in order to consent 40. information on early withdrawals is important to us and no extra subjects will be consented due to this.
Subjects who are non-compliant with the protocol may be discontinued from the study. Subjects who do not tolerate the dose of 2 g of DHa per day or who experience intolerable side effects will be discontinued. Subjects who choose to withdraw consent will be discontinued early.

Participant Eligibility

1. Male or females age 14-18 inclusive
2. Clinical diagnosis of concussion due to a sports-related injury.
The diagnosis of concussion must meet the following criteria:
a) Direct blow to the head, face, neck or a blow elsewhere on the body with
an
* impulsive
* force transmitted to the head.
b) Rapid onset of short-lived impairment of neurologic function in one or more of the
following clinical domains that resolves spontaneously:
1. symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or
emotional symptoms (eg, lability).
2. physical signs (eg, loss of consciousness, amnesia).
3. behavioural changes (eg, irritability).
4. cognitive impairment (eg, slowed reaction times).
5. sleep disturbance (eg, drowsiness).
c) No abnormality on standard structural neuroimaging studies, if such neuroimaging
studies are completed for a clinically-indicated reason.
3. Concussion within 4 days of enrollment
4. Presenting for treatment to the Sports Medicine Center at Children's Medical Center