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Recruiting NCT06208813

Creatine Supplementation in Concussion Recovery

No phase Interventional Concussion, Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Creatine.
Who it may be relevant to
Registry conditions: Concussion, Brain. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.

Overview

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.

Detailed 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.

Interventions

  • Dietary supplement Creatine
    Creatine supplementation

Primary outcome measures

  • Days to asymptomatic [Time frame: 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]
Secondary outcome measures (12)
  • Symptom evaluation - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Balance Error Scoring System - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Timed Tandem Gait - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Complex Tandem Gait - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Dual Task Gait Cognitive Accuracy Score - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Dual Task Gait Average Time - Sport Concussion Office Assessment Tool 6 [Time frame: 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]
  • Vestibular/Ocular-Motor Screening Smooth Pursuits [Time frame: 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]
  • Vestibular/Ocular-Motor Screening Saccades Horizontal [Time frame: 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]
  • Vestibular/Ocular-Motor Screening Saccades Vertical [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 18-35 years old with a diagnosed concussion within 72 hours post-injury

Exclusion criteria

  • Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • San Diego State University — San Diego

Publications

  • Roschel H, Gualano B, Ostojic SM, Rawson ES. Creatine Supplementation and Brain Health. Nutrients. 2021 Feb 10;13(2):586. doi: 10.3390/nu13020586. PMID 33578876
  • Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7. PMID 24601910
  • Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505. PMID 25232881
  • Harmon KG, Clugston JR, Dec K, Hainline B, Herring S, Kane SF, Kontos AP, Leddy JJ, McCrea M, Poddar SK, Putukian M, Wilson JC, Roberts WO. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019 Feb;53(4):213-225. doi: 10.1136/bjsports-2018-100338. PMID 30705232

Identifiers

NCT: NCT06208813 · Temp-4061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗