Clinical trial NCT06208813: Creatine Supplementation in Concussion Recovery
Official title: Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Days to asymptomatic
timeFrame: 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 outcomes:
measure: Symptom evaluation - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Balance Error Scoring System - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Timed Tandem Gait - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Complex Tandem Gait - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Dual Task Gait Cognitive Accuracy Score - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Dual Task Gait Average Time - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Smooth Pursuits
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Saccades Horizontal
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Saccades Vertical
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Convergence
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Vestibular-Ocular Reflex Horizontal
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Vestibular-Ocular Reflex Vertical
timeFrame: 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
measure: Vestibular/Ocular-Motor Screening Visual Motion Sensitivity Test
timeFrame: 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
measure: Anxiety Screen - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Depression Screen - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Sleep Screen - Sport Concussion Office Assessment Tool 6
timeFrame: 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
measure: Verbal memory - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Visual memory - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Psychomotor speed - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Reaction time - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Complex attention - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Cognitive Flexibility- CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Processing speed - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Executive function - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Simple Attention - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: Motor Speed - CNS Vital Signs
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
measure: King-Devick Visual Assessment
timeFrame: Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Michelle Weber Rawlins
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Roschel H, Gualano B, Ostojic SM, Rawson ES. Creatine Supplementation and Brain Health. Nutrients. 2021 Feb 10;13(2):586. doi: 10.3390/nu13020586.