Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents

This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

Study Overview

• Status: Withdrawn
• Conditions: Concussion, Mild; Traumatic Brain Injury, Mild
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Magnesium

Detailed Description

This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Spectrum Health Lakeland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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/allergy to magnesium, ondansetron, or acetaminophen
• pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days	Drug: Placebo; Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill
Experimental: Intervention; Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days	Dietary supplement: Magnesium; Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Concussion Symptom Severity Score	The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared	48, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effect related to medication administration	proportion of patients in each group who have developed of adverse effects related to medication administration	48, 72 hours
return to baseline	proportion of patients in each group who have experienced symptom resolution	48, 72 hours

Collaborators and Investigators

• Sponsor: Spectrum Health - Lakeland
• Investigators: Principal Investigator: Chris Trigger, DO, Spectrum Health - Lakeland

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Concussion
• Other Study ID Numbers: EGME#01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No