Creatine Monohydrate for Mild Traumatic Brain Injury: a Randomised Controlled Pilot Study
Creatine Monohydrate for Mild Traumatic Brain Injury: a Randomised Controlled Pilot Study
NCT ID: NCT06644131 Phase: NA Status: COMPLETED Enrollment: 34 Completion: 2024-12-31
Conditions
Mild Traumatic Brain Injury, Concussion (Diagnosis)
Interventions
Creatine Monohydrate, Sugar Pill (Placebo)
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 nee
Primary Outcome
Feasibility outcome