BCAAs in Concussion 3.0
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age11-23
SponsorAkiva Cohen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females,11 - 23 years of age.
Weigh at least 40kg.
Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
Present within 4 days of injury.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BCAA
DrugThe three BCAAs will be combined together into a powder formulation.
Placebo
Other interventionThe placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Drug: Branched Chain Amino AcidsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
28 daysSecondary outcomes
1
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.
This will be determined by a comparison of total score on the Post-concussion Symptom Scale (PCSS) (22 symptoms each rated on a 0-6 Likert scale, total scale of 0-132). A participant is deemed recovered when total score is within 3 points of their pre-injury score, time to recovery will be compared among placebo and control groups by Wilcoxon rank sum test.
Time frame
28 days2
Determine whether administration of BCAAs leads to a lower visio-vestibular abnormality burden compared to placebo.
This will be determined by the visio-vestibular examination (VVE) score, a score of 0-9 based on accumulation of abnormalities on the nine elements of the VVE. Average VVE score will be compared among placebo and control groups by Wilcoxon rank sum tests.
Time frame
28 days3
Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--maximum pupil diameter compared to placebo.
This will be determined by a comparison of the average maximum pupil diameter (measured in mm, scale 0-9 mm) between placebo and control using Wilcoxon rank sum test, whereby larger pupil diameter represents an abnormality.
Time frame
28 days4
Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--minimum pupil diameter compared to placebo.
This will be determined by a comparison of the average minimum pupil diameter (measured in mm, scale 0-9 mm) between placebo and control using Wilcoxon rank sum test, whereby larger pupil diameter represents an abnormality.
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Akiva Cohen
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Source ClinicalTrials.gov