A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in symptom severity score
研究概览
简要总结
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.
详细描述
Introduction Mild traumatic brain injuries are a growing problem in sports, and are now becoming publicly relevant. Mild traumatic brain injuries account for 700,000 ED visits, hospitalizations, and deaths annually. Today, 1 out of 5 adolescents will be affected by mild traumatic brain injuries. Magnesium is a critical neuromodulator that plays an important role in controlling neural signaling in the brain, and studies have shown a transiently low level of magnesium in CNS neurons following traumatic brain injury. If these electrolyte imbalances could be corrected with magnesium supplementation during the acute injury, this could potentially decrease the symptomatic period in those with mild TBI. The investigators aim to show a correlation between administration of PO magnesium and increased resolution of symptoms thereby improving the subjective recovery course of adolescents with concussion.
Study objective This randomized, cohort study will compare the clinical efficacy of PO magnesium and Zofran, to that of PO Tylenol and Zofran in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury.
Purpose With current studies and the sports media revolving around the long-term effects of repetitive mild TBI, it is important to continue to improve treatment of these injuries. Current therapy revolves around symptomatic care, rest, and return to school/sport after symptoms have resolved and the patient has been cleared by a physician. After a concussion, there is a period of 7-10 days where the patient has a transient decrease in the participants mental functioning. The investigators hope to decrease the length of the acute symptomatic period by supplementing oral magnesium along with the current symptomatic care. Studies have shown that IV magnesium in high doses can improve the function of patients with severe TBI. There have not been many studies looking at the efficacy of PO magnesium in this setting. While there is no evidence that concussions have long term effects on neurocognitive function, this study could add to the existing algorithm for concussion management.
Hypothesis The investigators believe that administration of magnesium in patients who present with mild traumatic brain injuries will decrease post concussive symptoms, thereby speeding recovery.
Methods Study design and setting Randomized, prospective, parallel cohort study comparing two non-invasive treatments for Mild traumatic brain injury in patients ages 12-18 that present to the Lakeland Health Emergency departments in either St. Joseph, MI or Niles, MI. The data collection period will take approximately 2 years with a minimum goal of 76 patients enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will be assigned a 3 digit number given at random and treatment arm will be randomized to day of presentation with treatment determined by even or odd day of the month
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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.
排除标准
- •• 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
研究组 & 干预措施
Treatment arm
Patients will receive PO magnesium 400 mg, Zofran 4 mgODT, and Tylenol 500 mg in the emergency department. They will then continue with 500 mg Tylenol BID and 400 mg MagOx tablets BID for the next 5 days. Symptom severity scores will be obtained and compared throughout this time as mentioned in the study design.
干预措施: Magnesium Oxide (Drug)
Treatment arm
Patients will receive PO magnesium 400 mg, Zofran 4 mgODT, and Tylenol 500 mg in the emergency department. They will then continue with 500 mg Tylenol BID and 400 mg MagOx tablets BID for the next 5 days. Symptom severity scores will be obtained and compared throughout this time as mentioned in the study design.
干预措施: Acetaminophen (Drug)
Treatment arm
Patients will receive PO magnesium 400 mg, Zofran 4 mgODT, and Tylenol 500 mg in the emergency department. They will then continue with 500 mg Tylenol BID and 400 mg MagOx tablets BID for the next 5 days. Symptom severity scores will be obtained and compared throughout this time as mentioned in the study design.
干预措施: Zofran ODT 4 MG Disintegrating Oral Tablet (Drug)
Placebo arm
Patients will receive PO Zofran 4 mgODT, and Tylenol 500 mg in the emergency department. They will then continue with 500 mg Tylenol BID for the next 5 days. Symptom severity scores will be obtained and compared throughout this time as mentioned in the study design.
干预措施: Acetaminophen (Drug)
Placebo arm
Patients will receive PO Zofran 4 mgODT, and Tylenol 500 mg in the emergency department. They will then continue with 500 mg Tylenol BID for the next 5 days. Symptom severity scores will be obtained and compared throughout this time as mentioned in the study design.
干预措施: Zofran ODT 4 MG Disintegrating Oral Tablet (Drug)
结局指标
主要结局
Change in symptom severity score
时间窗: 4 scores total, time 0, time 1 hour, time 24 hours, time 120 hours
Using post concussion symptom severity scores, the patient will complete symptom severity scores at specified intervals for comparison in post concussion severity score reduction. Higher scores indicate more severe symptoms, and lower scores indicate less severe symptoms.Post-Concussion Symptom Checklist Rating Mild Mod. Severe Initial 1 Hr. 48 Hr. 120 Hr. Headache 0-6 Nausea 0-6 Vomiting 0-6 Balance Problems 0-6 Dizziness 0-6 Visual Problems 0-6 Fatigue 0-6 Sensitivity to light 0-6 Sensitivity to noise 0-6 Numbness or Tingling 0-6 Pain other than Headache 0-6 Feeling as if "in a fog" 0-6 Feeling Slowed Down 0-6 Difficulty concentrating 0-6 Difficulty remembering 0-6 Drowsiness 0-6 Sleeping less than usual 0-6 Sleeping more than usual 0 1 2 3 4 5 6 Trouble falling asleep 0 1 2 3 4 5 6 More emotional than usual 0-6 Irritability 0-6 Sadness 0-6 Nervousness 0-6 Total Score
次要结局
- Adverse events in the emergency department(5 days)