BCAAs in Concussion 3.0
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BCAA, Placebo.
- Кому может быть актуально
- Состояния в реестре: Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury, Concussion, Brain, Concussion. Базовые параметры: 11 лет — 23 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат BCAA
The three BCAAs will be combined together into a powder formulation. - Другое Placebo
The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
Первичные конечные точки
- 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. [Срок оценки: 28 days]
Вторичные конечные точки (12)
- 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. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to a lower visio-vestibular abnormality burden compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--maximum pupil diameter compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--minimum pupil diameter compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-percentage of pupil constriction compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-constriction latency compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average constriction velocity compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--peak constriction velocity compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average dilation velocity compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-peak dilation velocity compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-T75 compared to placebo. [Срок оценки: 28 days]
- Determine whether administration of BCAAs leads to subjective improvement in sleep quality compared to placebo. [Срок оценки: 28 days]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Corwin DJ, Myers SR, Arbogast KB, Lim MM, Elliott JE, Metzger KB, LeRoux P, Elkind J, Metheny H, Berg J, Pettijohn K, Master CL, Kirschen MP, Cohen AS. Head Injury Treatment With Healthy and Advanced Dietary Supplements: A Pilot Randomized Controlled Trial of the Tolerability, Safety, and Efficacy of Branched Chain Amino Acids in the Treatment of Concussion in Adolescents and Young Adults. J Neuro PMID 38468511
Идентификаторы
NCT: NCT07670195 · 23-024503