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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Side effects data

From 2017 Phase 4 trial • 71 Patients • NCT02134808

64%

Headache

54%

Abdominal cramp, Nausea, Indigestion, Diarrhea

36%

Respiratory

Suicidal Ideation/Behavior

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Creatine

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

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