Creatine Supplementation in Concussion Recovery — CSCR  

Concussion, Brain Clinical Trial

Official title: Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.

Status Recruiting

Clinical Trial Summary

The proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine.Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic.Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic.

The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, The investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (Sport Concussion Office Assessment Tool-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.

Clinical Trial Description

Our proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine. Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic. Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic.

Once the research team is contacted about a potential injury, the investigators will ensure the participant meets inclusion criteria prior to meeting and schedule a meeting if meet inclusion criteria to explain study details, obtain informed consent, administer a symptom checklist (Sport Concussion Office Assessment Tool-5, SCOAT-6) and demographic questionnaire, and provide creatine. The investigators will use the following components of the SCAOT-6: Removal from play and description, (Current Injury; p. 652), Symptom Evaluation (p. 654-655), Verbal Cognitive Tests (p. 655), Digits Backwards (p. 656), Months in Reverse (p. 656), Orthostatic Vital Signs (p.657), Balance (p. 658), Timed Tandem Gait (p. 658), Complex Tandem Gait (p. 659), Dual Task Gait (p.659), Modified Vestibular/Ocular-Motor Screen (p. 660), Anxiety Screen (p. 660), Depression Screen (p. 660), sleep screen (p. 661), Delayed Word Recall (p. 662) (requires approximately 1 hour). Participants will be randomly assigned to the intervention or control group (10 participants targeted for each group; participant identification numbers will be predetermined and allocated once enrolled). 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. The control group will be asked to consume their usual diet and no creatine. The investigators will then remain in contact with the participant to ensure compliance, and assess when the participant is asymptomatic. When the investigators contact the participant will vary depending on recovery process (e.g., if a participant has high symptom burden, they may allow a few days between contact; whereas if a participant is nearing asymptomatic, they contact the participant more frequently).

Once the participant becomes asymptomatic, the investigators will meet to administer a SCAOT-6, a computerized neurocognitive assessment (CNS Vital Signs), visual assessment (King-Devick) and note days from injury to asymptomatic. CNS Vital Signs requires approximately 20-25 minutes and assesses the domains of verbal and visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, simple attention, and motor speed. King-Devick is a visual assessment asking participants to read three test cards with numbers as fast as possible without committing errors. The investigators anticipate the assessment requiring approximately 1.5 hours.

The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, the investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (SCOAT-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine. ;

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

• NCT number: NCT06208813
• Study type: Interventional
• Source: San Diego State University
• Contact: Michelle Weber Rawlins, PhD, ATC
• Phone: 619-594-1924
• Email: mrawlins@sdsu.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Completion date: May 31, 2025