Concussion, BrainCSCRNCT06208813
Creatine Supplementation in Concussion Recovery
A study testing Creatine in people with Concussion, Brain, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-35 years old with a diagnosed concussion within 72 hours post-injury
Who cannot join
- Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92812
Michelle L Weber Rawlins, PhD,ATC, (619) 594-1924, mrawlins@sdsu.edu
About this study
Official title: Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.
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.
Read the 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.
- Conditions
- Concussion, Brain
- Being tested
- Creatine
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Creatine supplementation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will consume their normal daily diet. |
| Creatine supplementation | Experimental | 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. Receives: Dietary Supplement: Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to asymptomatic
Days to asymptomatic
Measured: 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 (30)
Symptom evaluation - Sport Concussion Office Assessment Tool 6
22 item symptom list rated on a scale of 0-6 (0=none, 6=severe).
Measured: 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
Mental status assessment scored out of 45.
Measured: 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
Blood pressure (mmHG) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score.
Measured: 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
Heart rate (BPM) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score.
Measured: 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
Six stances completed on firm and foam surface (double leg, tandem, single leg stances). Errors counted including lifting hands off hips, opening eyes, 30 degrees of hip abduction, putting foot down in single leg stance, and/or remaining out of position for great than 5 seconds.
Measured: 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
Walking 3-metre-long line on firm surface heel-to-toe. Three trials completed measured in seconds, and average of trials used as measurement.
Measured: 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
Participants instructed to "walk heel-to-toe quickly five steps forward, then continue forward with eyes closed for five steps." Points are counted for each step off the line, 1 point for truncal sway or holding onto an object for support. Completed again backwards. Total points are included for a single score (forward plus backward points).
Measured: 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
Patients are instructed "Now, while you are walking heel-to-toe, I will ask you to recite the following words in reverse order/count backwards out loud by 7's/ recite the months of the year in reverse order." We will measure the cognitive accuracy score (number correct/number attempted).
Measured: 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
Patients are instructed "Now, while you are walking heel-to-toe, I will ask you to recite the following words in reverse order/count backwards out loud by 7's/ recite the months of the year in reverse order." We will measure the average time (seconds).
Measured: 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
Test the ability to follow a slowly moving target. The patient and the examiner are seated. The examiner holds a fingertip at a distance of 3 ft. from the patient. The patient is instructed to maintain focus on the target as the examiner moves the target smoothly in the horizontal direction 1.5 ft. to the right and 1.5 ft. to the left of midline. One repetition is complete when the target moves back and forth to the starting position, and 2 repetitions are performed. The target should be moved at a rate requiring approximately 2 seconds to go fully from left to right and 2 seconds to go fully from right to left. The test is repeated with the examiner moving the target smoothly and slowly in the vertical direction 1.5 ft. above and 1.5 ft. below midline for 2 complete repetitions up and down. Again, the target should be moved at a rate requiring approximately 2 seconds to move the eyes fully upward and 2 seconds to move fully downward. Symptoms measured on a scale of 0-6.
Measured: 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
The examiner holds two single points (fingertips) horizontally at a distance of 3 ft. from the patient, and 1.5 ft. to the right and 1.5 ft. to the left of midline so that the patient must gaze 30 degrees to left and 30 degrees to the right. Instruct the patient to move their eyes as quickly as possible from point to point. One repetition is complete when the eyes move back and forth to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6.
Measured: 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
Repeat the test with 2 points held vertically at a distance of 3 ft. from the patient, and 1.5 feet above and 1.5 feet below midline so that the patient must gaze 30 degrees upward and 30 degrees downward. Instruct the patient to move their eyes as quickly as possible from point to point. One repetition is complete when the eyes move up and down to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6.
Measured: 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 Convergence
Measure the ability to view a near target without double vision. The patient is seated and wearing corrective lenses (if needed). The examiner is seated front of the patient and observes their eye movement during this test. The patient focuses on a small target (approximately 14 point font size) at arm's length and slowly brings it toward the tip of their nose. The patient is instructed to stop moving the target when they see two distinct images or when the examiner observes an outward deviation of one eye. Blurring of the image is ignored. The distance in cm. between target and the tip of nose is measured and recorded. Abnormal: Near Point of convergence ≥ 6 cm from the tip of the nose.
Measured: 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 Vestibular-Ocular Reflex Horizontal
The patient is asked to rotate their head horizontally while maintaining focus on the target. The head is moved at an amplitude of 20 degrees to each side and a metronome is used to ensure the speed of rotation is maintained at 180 beats/minute (one beat in each direction). One repetition is complete when the head moves back and forth to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea and Fogginess ratings 10 sec after the test is completed. Symptoms measured on a scale of 0-6.
Measured: 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 Vestibular-Ocular Reflex Vertical
The test is repeated with the patient moving their head vertically. The head is moved in an amplitude of 20 degrees up and 20 degrees down and a metronome is used to ensure the speed of movement is maintained at 180 beats/minute (one beat in each direction). One repetition is complete when the head moves up and down to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea and Fogginess ratings after the test. Symptoms measured on a scale of 0-6.
Measured: 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 Visual Motion Sensitivity Test
Test visual motion sensitivity and the ability to inhibit vestibular-induced eye movements using vision. The patient stands with feet shoulder width apart, facing a busy area of the clinic. The examiner stands next to and slightly behind the patient, so that the patient is guarded but the movement can be performed freely. The patient holds arm outstretched and focuses on their thumb. Maintaining focus on their thumb, the patient rotates, together as a unit, their head, eyes and trunk at an amplitude of 80 degrees to the right and 80 degrees to the left. A metronome is used to ensure the speed of rotation is maintained at 50 beats/min (one beat in each direction). One repetition is complete when the trunk rotates back and forth to the starting position, and 5 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6.
Measured: 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
Anxiety Screen - Sport Concussion Office Assessment Tool 6
Participants are asked to rate seven items on a 0-3 point Likert-scale (0=Not at all, 3=Nearly every day). Scores are totaled and categorized into 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, 15-21=severe anxiety.
Measured: 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
Depression Screen - Sport Concussion Office Assessment Tool 6
Participants are asked to rate two items with a variety of item responses. Scores are totaled with a cutpoint being 3 for depression.
Measured: 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
Sleep Screen - Sport Concussion Office Assessment Tool 6
Participants are asked to rate five items on a 0-3 point Likert-scale (0=Not at all, 3=Nearly every day). Item responses are total then categorized with 0-4=normal, 5-7 mild, 8-10 moderate, 11-17 severe clinical sleep disorder.
Measured: 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
Verbal memory - CNS Vital Signs
Measures how well subject can recognize, remember, and retrieve words. Calculated using VBM (verbal memory) Correct Hits Immediate + VBM Correct Passes Immediate + VBM Correct Hits Delay + VBM Correct Passes Delay).
Measured: 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
Visual memory - CNS Vital Signs
Measures how well subject can recognize, remember, and retrieve geometric figures. Calculated VIM (visual memory) Correct Hits Immediate + VIM Correct Passes Immediate + VIM Correct Hits Delay + VIM Correct Passes Delay).
Measured: 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
Psychomotor speed - CNS Vital Signs
Measures how well a subject perceives, attends, responds to visual-perceptual information, and performs motor speed and fine motor coordination. Calculated finger tapping test (FTT) Right Taps Average + FTT Left Taps Average + Symbol Digit Coding Test Correct Responses.
Measured: 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
Reaction time - CNS Vital Signs
Measures how quickly the subject can react, in milliseconds, to a simple and increasingly complex direction set. Calculated by Stroop Test Complex Reaction Time Correct + Stroop Reaction Time Correct) / 2.
Measured: 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
Complex attention - CNS Vital Signs
Measures one's ability to track and respond to a variety of stimuli over lengthy periods of time and/or perform mental tasks requiring vigilance quickly and accurately. Calculated by Stroop Commission Errors + Shifting Attention Test Errors + Continuous Performance Test Commission Errors + Continuous Performance Test Omission Errors
Measured: 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
Cognitive Flexibility- CNS Vital Signs
Measures how well subject is able to adapt to rapidly changing and increasingly complex set of directions and/or to manipulate the information.Calculated with Shifting Attention Test Correct Responses - Shifting Attention Test Errors - Stroop Commission Error
Measured: 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
Processing speed - CNS Vital Signs
Measures how well a subject recognizes and processes information i.e., perceiving, attending/responding to incoming information, motor speed, fine motor coordination, and visual-perceptual ability. Calculated with Symbol Digit Coding Correct Responses - Symbol Digit Coding Errors
Measured: 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
Executive function - CNS Vital Signs
Measures how well a subject recognizes rules, categories, and manages or navigates rapid decision making. Calculated with Shifting Attention Test Correct Responses - Shifting Attention Test Errors
Measured: 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
Simple Attention - CNS Vital Signs
Measures one's ability to track and respond to a single defined stimulus over lengthy periods of time while performing vigilance and response inhibition quickly and accurately. Calculated with Continuous Performance (CPT) Correct Responses minus CPT Commission Errors.
Measured: 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
Motor Speed - CNS Vital Signs
Measures one's ability to perform movements to produce and satisfy an intention towards a manual action and goal. Calculated with Finger Tapping Test Right Taps Average + Finger Tapping Test Left Taps Average.
Measured: 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
King-Devick Visual Assessment
Visual assessment; The King-Devick Test is a two-minute rapid number naming assessment in which an individual quickly reads aloud single digit numbers and evaluates impairments of eye movements, attention and language function; fastest assessment of three cards measured in seconds
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Feb 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Weber Rawlins, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208813
- Sponsor's protocol ID
- Temp-4061
- Acronym
- CSCR
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33578876Broglio 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.
PubMed 24601910Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505.
PubMed 25232881Harmon 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.
PubMed 30705232
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.
- ClinicalTrials.gov ID
- NCT06208813
- Acronym / sponsor ID
- CSCR / Temp-4061
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will consume their normal daily diet. |
| Creatine supplementation | Experimental | Dietary Supplement: CreatineThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35 years old with a diagnosed concussion within 72 hours post-injury
Key exclusion criteria (1 listed)
- Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineCreatine supplementation | Dietary supplement | Creatine supplementation |
Primary outcome
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
Days to asymptomatic
30 secondary outcomes
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
Vestibular/Ocular-Motor Screening Convergence
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 Vestibular-Ocular Reflex 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 Vestibular-Ocular Reflex 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
Vestibular/Ocular-Motor Screening Visual Motion Sensitivity Test
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
Anxiety Screen - 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
Depression Screen - 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
Sleep Screen - 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
Verbal memory - CNS Vital Signs
Time frame: 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
Visual memory - CNS Vital Signs
Time frame: 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
Psychomotor speed - CNS Vital Signs
Time frame: 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
Reaction time - CNS Vital Signs
Time frame: 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
Complex attention - CNS Vital Signs
Time frame: 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
Cognitive Flexibility- CNS Vital Signs
Time frame: 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
Processing speed - CNS Vital Signs
Time frame: 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
Executive function - CNS Vital Signs
Time frame: 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
Simple Attention - CNS Vital Signs
Time frame: 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
Motor Speed - CNS Vital Signs
Time frame: 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
King-Devick Visual Assessment
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 33578876Roschel H, Gualano B, Ostojic SM, Rawson ES. Creatine Supplementation and Brain Health. Nutrients. 2021 Feb 10;13(2):586. doi: 10.3390/nu13020586.
- Results publication: PubMed 24601910Broglio 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.
- Results publication: PubMed 25232881Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505.
- Results publication: PubMed 30705232Harmon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Weber Rawlins principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Concussion, Brain, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Weber Rawlins, PhD, ATC (619-594-1924, mrawlins@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208813, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.