Your session is about to expire
← Back to Search
Dietary Supplement
Creatine for Concussion (CSCR Trial)
N/A
Recruiting
Led By Michelle Weber Rawlins
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if taking creatine helps people recover faster from concussions. They will compare how long it takes for people to become symptom-free after a concussion and also compare their concussion assessment scores
Who is the study for?
This trial is for individuals aged 18-35 who have been diagnosed with a concussion within the last 72 hours. It's not suitable for those outside this age range or if more time has passed since their injury.
What is being tested?
The study is testing whether taking creatine helps people recover from concussions faster and improves their brain function outcomes compared to those not taking it. Participants' recovery times and cognitive functions will be measured and compared.
What are the potential side effects?
Creatine is generally considered safe, but potential side effects can include muscle cramping, nausea, diarrhea, dizziness, gastrointestinal pain, dehydration, weight gain due to water retention, heat intolerance and fever.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Days to asymptomatic
Secondary study objectives
Anxiety Screen - Sport Concussion Office Assessment Tool 6
Balance Error Scoring System - Sport Concussion Office Assessment Tool 6
Cognitive Flexibility- CNS Vital Signs
+26 moreSide effects data
From 2017 Phase 4 trial • 71 Patients • NCT0213480864%
Headache
54%
Abdominal cramp, Nausea, Indigestion, Diarrhea
36%
Respiratory
4%
Suicidal Ideation/Behavior
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Creatine supplementationExperimental Treatment1 Intervention
The intervention group will consume their usual diet plus 5 grams of creatine for the first four days following the initial meeting, and then 3 grams of creatine once per day thereafter until asymptomatic.
Group II: Control GroupActive Control1 Intervention
Participants will consume their normal daily diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine
2014
Completed Phase 4
~670
Find a Location
Who is running the clinical trial?
San Diego State UniversityLead Sponsor
170 Previous Clinical Trials
115,061 Total Patients Enrolled
Michelle Weber RawlinsPrincipal InvestigatorSan Diego State University