Creatine Supplementation in Concussion Recovery (NCT06208813) | Clinical Trial Compass
RecruitingNot Applicable
Creatine Supplementation in Concussion Recovery
United States20 participantsStarted 2024-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-35 years old with a diagnosed concussion within 72 hours post-injury
Exclusion Criteria:
* Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring how many days it takes to become symptom-free after a concussion — is that the most important recovery goal for my specific situation, or are there other outcomes, like cognitive function or return-to-activity, that matter more for me?
2Since this trial is listed as Phase NA, which often means it's a nutritional or supplement study rather than a drug trial, can you help me understand what is actually known so far about creatine's safety and effectiveness for concussion recovery before I consider joining?
3Creatine is a supplement many people already take on their own — is there any reason I shouldn't just try it independently, and what does participating in a formal trial offer me that I couldn't get otherwise?
4How does the timing of enrollment work here — do I need to sign up within a certain window after my concussion for the supplementation to potentially have any effect, and would joining delay or interfere with any standard treatment you'd normally recommend?
5Are there any people with my type of concussion, age group, or health history who would not be a good fit for this trial, and is standard concussion management still a better first step for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days to asymptomatic
Timeframe: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks