Concussion, Brain Clinical Trial
— CSCROfficial 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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | May 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | San Diego State University | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| San Diego State University |
United States,
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 — View 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. — View 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;5 — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Days to asymptomatic | Days to asymptomatic | 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 | Symptom evaluation - Sport Concussion Office Assessment Tool 6 | 22 item symptom list rated on a scale of 0-6 (0=none, 6=severe). | 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 | Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6 | Mental status assessment scored out of 45. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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). | 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 | |
| Secondary | 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). | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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 | 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 |
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