CompletedEarly Phase 1

A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents

United States17 participantsStarted 2017-09-01

Plain-language summary

The objective of this study is to evaluate the efficacy of magnesium in symptomatic reduction of mild traumatic brain injury in the adolescent population in the acute setting of injury.

Who can participate

Age range12 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Age 12 to 18 years * • Presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury. * • GCS \> 13 on arrival. Exclusion Criteria: * • Age \< 12 years or \> 18 years * • Inability to provide informed consent * • Vomiting \> 2 episodes following injury * • Physical or mental disability hindering adequate response to assessment of symptoms * • Hemodynamic instability/medical condition requiring further acute life-saving medical intervention * • Known brain mass, intracranial hemorrhage, skull fracture * • Known contraindications to magnesium use * • Known contraindication to Zofran use

What they're measuring

Change in symptom severity score

Timeframe: 4 scores total, time 0, time 1 hour, time 24 hours, time 120 hours

Trial details

NCT IDNCT03475693

SponsorCorewell Health South

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-30

View on ClinicalTrials.gov More Concussion Post Syndrome trials