Creatine Supplementation in Concussion Recovery
ConditionConcussion, Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorSan Diego State University
About this trial
The proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine.Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic.Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic.
The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, The investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (Sport Concussion Office Assessment Tool-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-35 years old with a diagnosed concussion within 72 hours post-injury
Disqualifiers
Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
Creatine
Dietary supplementCreatine supplementation
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Creatine supplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Days to asymptomatic
Days to asymptomatic
Time frame
From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeksSecondary outcomes
1
Symptom evaluation - Sport Concussion Office Assessment Tool 6
22 item symptom list rated on a scale of 0-6 (0=none, 6=severe).
Time frame
From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks2
Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6
Mental status assessment scored out of 45.
Time frame
From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks3
Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6
Blood pressure (mmHG) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score.
Time frame
From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks4
Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6
Heart rate (BPM) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score.
Time frame
From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeksSponsors and contacts
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Source ClinicalTrials.gov