HIT HEADS 3.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants that have met have met criteria for recovery at 28 days post-injury, defined as return to baseline symptom levels along with feeling > 90% back to normal.
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 (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.
详细描述
Annually, approximately 2 million concussions occur in the pediatric and young adult population. Approximately 30% of those diagnosed with concussion will experience persisting symptoms lasting beyond 28 days. Concussion is a heterogeneous injury to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no targeted therapeutics that can mitigate or prevent the deleterious effects of concussion. In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain amino acids (BCAAs) (valine, isoleucine, and leucine) were significantly reduced after injury. When these brain-injured animals received dietary supplementation with BCAAs, 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. The pilot study (NCT01860404) provides evidence of BCAAs in concussed adolescents and young adults providing a dose-response effect in reducing concussion symptoms and a return to baseline physical activity in those treated with higher total doses of BCAAs. This third trial was developed to inform clinical practice around BCAA treatment in concussion in a new formulation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females,11 - 23 years of age.
- •Weigh at least 40kg.
- •Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
- •a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality.
- •Present within 4 days of injury.
- •Post-menarchal females must have a negative urine pregnancy test.
- •Informed consent by the participant, or for participants <18 years old both informed consent by a parent/guardian and child assent.
排除标准
- •Evidence of moderate or severe TBI, including GCS <13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
- •Prior concussion or TBI within 90 days.
- •Known history of maple syrup urine disease or known family history of maple syrup urine disease.
- •Any investigational drug use within 30 days prior to enrollment.
- •Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
- •Non-English speaking participants or parent/guardian.
研究组 & 干预措施
Placebo
The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
干预措施: Placebo (Other)
Drug: Branched Chain Amino Acids
The three BCAAs will be combined together into a powder formulation.
干预措施: BCAA (Drug)
结局指标
主要结局
Number of participants that have met have met criteria for recovery at 28 days post-injury, defined as return to baseline symptom levels along with feeling > 90% back to normal.
时间窗: 28 days
This will be determined by research staff at in person visits by the return to baseline symptom levels along with participant self-report of feeling \> 90% back to normal. Percentage recovered at 28 days will be compared between placebo and control group by chi-square testing.
次要结局
- Determine whether administration of high-dose BCAAs (30g/day) compared to placebo supplementation, promotes concussion recovery operationalized by the return to baseline (pre-injury) concussion symptom levels.(28 days)
- Determine whether administration of BCAAs leads to a lower visio-vestibular abnormality burden compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--maximum pupil diameter compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--minimum pupil diameter compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-percentage of pupil constriction compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-constriction latency compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average constriction velocity compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--peak constriction velocity compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average dilation velocity compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-peak dilation velocity compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-T75 compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to subjective improvement in sleep quality compared to placebo.(28 days)
- Determine whether administration of BCAAs leads to subjective improvement in physical activity compared to placebo.(28 days)
研究者
Akiva Cohen
Researcher
Children's Hospital of Philadelphia