Creatine monohydrate for treating persistent post-concussive symptoms
The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms - a Pilot Study Protocol
NA · Psychiatric Research Unit, Region Zealand, Denmark · NCT05562232
This study is testing if taking creatine can help people with ongoing symptoms after a mild brain injury feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | All |
| Sponsor | Psychiatric Research Unit, Region Zealand, Denmark (other) |
| Locations | 1 site (Odense) |
| Trial ID | NCT05562232 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of creatine monohydrate supplementation on patients suffering from persistent post-concussive symptoms (PPCS) following mild traumatic brain injury (mTBI). Participants will complete self-reported questionnaires to assess the number and severity of their symptoms over a specified period. The study aims to determine if creatine, known for its role in muscle development, can also benefit brain metabolism and alleviate PPCS symptoms. The research is motivated by the significant prevalence of mTBI and the lack of effective treatment options currently available.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 45 who have experienced persistent post-concussive symptoms for 6 to 18 months.
Not a fit: Patients who are elite athletes or engage in high levels of physical activity, as well as those with PPCS for less than 6 months or more than 18 months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for patients suffering from persistent post-concussive symptoms.
How similar studies have performed: While there is limited research on creatine for PPCS, preliminary studies suggest potential benefits in related areas, indicating this approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have had PPCS for a minimum of six months and a maximum of 18 months at the start of the study. * Being between 20 and 45 years of age Exclusion Criteria: * Elite athletes, as well as people who in general is physical active, at an intensity of moderat to high, for more than ten hours a week on average. * Participation in other interventions/treatment that could affect this study * Have had PPCS in: * =\<6 months * =\>18 months * Pregnant
Where this trial is running
Odense
- University of Southern Denmark — Odense, Denmark (RECRUITING)
Study contacts
- Principal investigator: Michael Marcussen, Dr. — University of Southern Denmark (SDU), Denmark
- Study coordinator: Ronni Lykke Bødker, MSc
- Email: ronni@commotio.dk
- Phone: +45 61710188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Traumatic Brain Injury, Concussion, Brain, Concussion, Mild traumatic brain injury, Creatine monohydrate, Persistent post-concussive symptoms