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临床试验/NCT01860404
NCT01860404已完成2 期

Head Injury Treatment With Healthy and Advanced Dietary Supplements (HIT HEADS): A Randomized, Placebo-controlled, Double-blinded, Therapeutic Exploratory Clinical Trial of Branched Chain Amino Acids (BCAA's) in the Treatment of Concussion

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Reaction Time Difference Between Drug and Placebo Groups

研究概览

简要总结

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

详细描述

Annually, between 100,000 to 140,000 children present to the emergency department for concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 - 3.8 million sports related concussions occur each year in the United States. A large proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion is a heterogeneous insult to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no proven therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is often damaged in concussion. In preclinical studies in our laboratory, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were significantly altered (reduced) after injury. When these brain-injured animals received dietary supplementation with BCAA's, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. In light of these results and the increasing awareness and morbidity associated with concussion, we are proposing a pilot therapeutic exploratory clinical trial to determine the effects of BCAA's in reducing the neurocognitive side effects of concussion injury.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 34 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo will be administered orally twice daily for 21 days

干预措施: Placebo solution (Drug)

Branched Chain Amino Acids (27g BID)

Experimental

27 grams of BCAA's will be administered twice-daily for 21 days

干预措施: Branched Chain Amino Acids (Drug)

Branched Chain Amino Acids (22.5g BID)

Experimental

22.5 grams of BCAA's will be administered twice-daily for 21 days

干预措施: Branched Chain Amino Acids (Drug)

Branched Chain Amino Acids (15g BID)

Experimental

15 grams of BCAA's will be administered twice-daily for 21 days

干预措施: Branched Chain Amino Acids (Drug)

Branched Chain Amino Acids (7.5g BID)

Experimental

7.5 grams of BCAA's will be administered twice-daily for 21 days

干预措施: Branched Chain Amino Acids (Drug)

结局指标

主要结局

Reaction Time Difference Between Drug and Placebo Groups

时间窗: Day 21

Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed.

次要结局

  • Tolerability of BCAA's Based on Adverse Events(Day 21)
  • Return to Physical Activity Baseline(Day 21)
  • Neurocognitive Recovery-- Attention(Day 21)
  • Compliance and Adherence to Treatment(Day 21)
  • Neurocognitive Recovery-- Working Memory(Day 21)
  • Neurocognitive Recovery-- Visual Memory(Day 21)
  • Clinical Symptoms(Day 21)
  • Safety and BCAA Supplementation(Day 21)
  • Return to Baseline Cognitive Activity(Day 21)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sage R Myers

Attending Physician

Children's Hospital of Philadelphia

研究点 (1)

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