CompletedNot Applicable

Creatine Monohydrate for Mild Traumatic Brain Injury: a Randomised Controlled Pilot Study

Denmark34 participantsStarted 2023-08-01

Plain-language summary

Objectives: Approximately one-third of patients with concussion experience persistent symptoms that, in addition to causing serious discomfort, may lead to unemployment and other socioeconomic challenges. Animal studies suggest that creatine monohydrate may alleviate post-concussive symptoms. This pilot study investigated the effects of creatine monohydrate on post-concussive symptoms in humans and assessed the feasibility of the pilot trial. Design: Three-arm randomised controlled pilot trial (intervention, placebo, control). Setting: Participants were recruited through neurological outpatient clinics and public outreach in Denmark. Participants: The study included 34 participants aged 20-45 years who had been experiencing persistent post-concussive symptoms for 6-18 months since injury. Participants were randomised to one of three groups. Intervention: The intervention group received 5 g of creatine monohydrate daily for seven weeks. The placebo group received an identical inert powder following the same regimen. The control group received usual care only. Primary and secondary outcome measures: The primary outcome was post-concussion symptoms (Rivermead Post Concussion Symptoms Questionnaire (RPQ)). Secondary outcomes were acute (RPQ-3) and persistent (RPQ-13) symptoms, assessed at three time points (week 0, 4 and 8). Results: All participants completed follow-up, indicating the trial's high feasibility and practicality. The intervention group did not significantly differ from the placebo or control groups. Moderate effect sizes were noted for RPQ-13 and total RPQ scores (d = -0.47, -0.46) and small for RPQ-3 scores (d = -0.22), although none reached statistical significance. Similar effects were observed between the placebo and control groups. Conclusions: The study showed strong usability and practical feasibility. Effect sizes were exploratory and not indicative as evidence of treatment efficacy at this stage. Larger randomized controlled trials are needed to determine whether creatine monohydrate could be a safe, accessible adjunctive treatment for post-concussive symptoms.

Who can participate

Age range

20 Years – 45 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: * The time since concussion was 6-18 months. * The age range was 20-45 years. * Only participants who had not initiated any new pharmacological or non-pharmacological treatments from three weeks prior to inclusion until study completion were eligible Exclusion Criteria: * Moderat to high level of intensity for no more than 10 hours per week * Pregnant

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.

1Since this was a pilot study focused on feasibility rather than proving that creatine monohydrate actually works for concussion recovery, what does my doctor think the current evidence realistically shows about its effectiveness for mild traumatic brain injury?
2This trial has already been completed — would it be worth asking my doctor if the results have been published yet, and whether those findings change how they think about creatine as a supplement after a concussion?
3Given that this was a randomised controlled pilot study, meaning it was likely small and designed mainly to test whether a larger trial is doable, how much weight should I give its findings when deciding whether creatine monohydrate is something to consider for my own recovery?
4Creatine monohydrate is available over the counter, but would my doctor advise against starting it on my own without understanding the dosing protocol or timing that was used in this specific trial?
5Are there standard, already-established treatments for mild traumatic brain injury or concussion that my doctor would recommend I try first, before looking at supplements that are still being studied in early-phase research like this?

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

Feasibility outcome

Timeframe: From enrollment to the end of treatment at 8 weeks.

Trial details

NCT IDNCT06644131

SponsorUniversity of Southern Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials