← Back to Search

Dietary Supplement

Creatine supplementation 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

CSCR Trial 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.Check my eligibility

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.See study design

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.

CSCR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days to asymptomatic

Secondary outcome measures

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 2015 Phase 3 trial • 50 Patients • NCT02188849

18%

Pain

14%

Falls

14%

Gastroinftestinal symptoms

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Creatine

CSCR 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor

154 Previous Clinical Trials

116,108 Total Patients Enrolled

Michelle Weber RawlinsPrincipal InvestigatorSan Diego State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participants in this study inclusive of individuals under 25 years old?

"This investigation is open to individuals over 18 years old but under the age of 35."

Answered by AI

Are there any ongoing efforts to enroll participants in this current medical study?

"As per the details available on clinicaltrials.gov, eligible participants can currently enroll in this clinical trial. The trial was initially listed on 2/1/2024 and last revised on 4/15/2024."

Answered by AI

What is the number of participants currently involved in this clinical investigation?

"Indeed, clinicaltrials.gov confirms that this investigation is actively seeking volunteers. This study was first shared on 2/1/2024 and most recently revised on 4/15/2024. It aims to recruit a total of 20 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Creatine Supplementation in Concussion Recovery

Michelle Weber Rawlins 2024. "Creatine Supplementation in Concussion Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208813.

All > Concussion