Concussion, MildNCT04641832
The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health
A study testing Soccer heading in people with Concussion, Mild, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this pilot study is to better understand the effects of chronic cannabis (THC) use on the neural responses to subconcussive head impacts, as a form of repetitive soccer headings. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Soccer heading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Chronic THC User Group
- being between 18 to 26 years of age
- self-reported chronic THC use (average use once per week but not dependent)3) at least 3 years of soccer heading experience.
- For Non-User Cohort
- being between 18 to 26 years of age
- self-reported non cannabis use in the past 6 months
- at least 3 years of soccer heading experience
Who cannot join
- any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
- history of vestibular, ocular, or vision dysfunction (e.g., macular degeneration)
- currently taking any medications affecting balance (e.g., antibiotics)
- pregnancy
- HIV
- any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, spinal cord injury/surgery, history of stroke)
Show all 15Show fewer
- hypertension, cardiac arrhythmia, or pulmonary disease
- lower extremity injury that would prohibit performing soccer headings
- metal implants in the head
- Session-specific exclusion criteria will include:
- used cannabis within the last 72 hours (verified by saliva cannabis test before intervention)
- slept less than 4 hours before the 1st and 2nd test day (verified by screening questionnaire)
- drank any alcoholic drinks or used recreational drugs 72 hours before the 1st test day and during the study period.
- drank more than 3 cups of coffee before any test sessions
- glasses are prohibited (contact lenses are okay) for safety purpose for the heading intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
Official title: The Effect of Chronic Cannabis Use on Neural Response to Acute Subconcussive Head Impacts
The purpose of this pilot study is to better understand the effects of chronic cannabis (THC) use on the neural responses to subconcussive head impacts, as a form of repetitive soccer headings. The study is designed to identify the physiological changes of cannabis using cohort (THC) and compare it to a nonusing cohort in order to see if the responses to 20 controlled bouts of soccer headings are exacerbated by the chronic cannabis use, diminished to less of a response, or unchanged, through an array of neurologic measures, including cognitive function, ocolar-motor function, autonomic function, and blood biomarkers. The hypothesis is that repetitive subconcussive head impacts will impair cognitive function in worse memory, attention span, and visual and verbal problem solving; this impairment will be greater in the chronic cannabis use groups than non-using group. The blood and salivary biomarkers neurofilament light (NFL) and glial fibrillary acidic protein (GFAP) will be measured in plasma, with the hypothesis that repetitive subconcussive head impacts will significantly increase plasma NFL and GFAP level at 24 hours-post heading and decrease by 72 hours-post heading, while remaining undetectable at 2 hours-post heading; the chronic cannabis use groups will see more severe effects on ocular-motor function than the non-using group. The study aims to determine the differences in acute effects of subconcussive head impacts on eye movement, attention, and language function between chronic cannabis use subjects and non-using subjects by evaluating ocular-motor function with near point of convergence and King-Devick tests. The hypothesis is that repetitive subconcussive head impacts will significantly increase impairments of eye movements, attention, and language function, as well as near point of convergence; the chronic cannabis use groups will see more severe effects on hampered ocular-motor function than the non-using group. Lastly, there is a cold pressor test to assess autonomic nerve function, with the hypothesis that repetitive subconcussive head impacts will decrease autonomic nerve function in chronic cannabis use patients to a greater degree than non-using subjects.
Read the detailed description
NUMBER OF PEOPLE TAKING PART IN THE STUDY
We plan to recruit 45 THC using subjects and 45 non-using subjects.
PROCEDURES FOR THE STUDY
Participants will be assigned to the THC cannabis user group or the nonuser group based on participants' report of past cannabis use. These groups will then be verified using saliva and urine tests for cannabis use history.
The study consists of 4 test sessions during a 4-day period. The 1st day will take approximately 4 hours. The 2nd and 4th day will each take approximately 1 hour. Participants will not need to do anything on the 3rd day.
- The 1st test session takes place right before the soccer heading intervention.
- After the 1st test session, participants will then perform 20 soccer headings in 10 minutes.
- The 2nd test session takes place 2h after the intervention.
- The 3rd test session takes place approximately 24h after the intervention.
- The 4th test session takes place approximately 72h after the intervention.
During each test session, participants will be asked to complete a paper-pencil questionnaire assessing participants' current feeling. The questionnaire consists of 22 possible symptoms with 7-point scale to see if participants are experiencing concussion-related symptoms. A trained phlebotomist will draw blood from a vein in participants' arm at the four time points described in the above bulletpoints. Each 4mL blood sample is equivalent to approximately 1 teaspoon. A total of approximately 16mL (3-4 teaspoons) will be drawn during this study. The researchers will collect saliva samples (2mL) at each time point. Participants will be then asked to perform eye-movement tasks with directions from the research assistant. The eye-movement tasks consist of watching an object nearing the face (called a convergence test) and a brief test that asks participants to name numbers aloud from a screen. These eye-movement tasks will be repeated twice and will take about 2 minutes. After eye-movement testing, the investigators will ask participants to complete an imPACT test, which is a computerized test commonly used to diagnose concussions that measures memory, attention span, and visual and verbal problem solving. Completing the imPACT takes 20 to 25min. The last test is an autonomic function test, where participants will place participants' hand in a bowl of ice water for 60s while participants' heartrate is recorded.
The first 1st test session is slightly longer than the other two. It requires a saliva collection, where participants are asked to collect saliva in his/her mouth for approximately 15s before spitting onto a test strip. Researchers will need to collect about 7mL (1.5 teaspoon) of saliva from participants. This test will verify that participants have not used cannabis products in the past 72 hours. participants will also be asked for a urine sample. A urine sample of approximately 50mL will be used to verify cannabis use history over the past 3 months.
During the 1st day, after finishing the 1st test session, participants will perform 20 soccer headings. A standard size 5 soccer ball will be projected at 25 mph (equivalent speed to a long throw-in) by a JUGS soccer machine, and participants will perform 20 headers with 30 seconds resting period between each header. participants will be asked to direct the ball back towards the JUGS soccer machine in the air.
- Conditions
- Concussion, Mild
- Being tested
- Soccer heading
- Keywords
- soccer heading, subconcussive head impacts, cannabis
- Medical subject headings
- Brain Concussion, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soccer headingOther
A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 standing headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.
| Study group | Role | What they receive |
|---|---|---|
| Chronic cannabis use and subconcussive head impacts | Experimental | Group: Chronic cannabis users Criteria: self-reported chronic THC use (average use once per week but not dependent). Urine cannabis test must show positive.
Device: Soccer Heading Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 20 consecutive soccer headings, separated by one minute intervals. Receives: Other: Soccer heading |
| Non-cannabis use and subconcussive head impacts | Active comparator | Group: Non cannabis users Criteria: self-reported none THC use. Urine cannabis test must show negative.
Device: Soccer Heading Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 20 consecutive soccer headings, separated by one minute intervals. Receives: Other: Soccer heading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in brain-derived blood and saliva biomarkers from pre to 24 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis.
Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Measured: Blood samples will be collected at pre- and 24 hour post-heading
Acute change in brain-derived blood and saliva biomarkers from pre to 2 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis.
Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Measured: Blood and saliva samples will be collected at pre- and 2 hour post-heading
Acute change in neurocognitive function from pre to 2 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Measured: Neurocognitive function will be assessed at pre- and 2 hour post-heading
Acute change in neurocognitive function from pre to 24 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Measured: Neurocognitive function will be assessed at pre- and 24 hour post-heading
Acute change in ocular-motor function from pre to 2 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
Measured: Ocular-motor function will be assessed at pre- and 2 hour post-heading
Acute change in ocular-motor function from pre to 24 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
Measured: Ocular-motor function will be assessed at pre- and 24 hour post-heading
Secondary outcomes (6)
Acute change in brain-derived blood and saliva biomarkers from pre to 72 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis.
Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Measured: Blood and saliva samples will be collected at pre- and 72 hour post-heading
Acute change in neurocognitive function from pre to 72 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Measured: Neurocognitive function will be assessed at pre- and 72 hour post-heading
Acute change in ocular-motor function from pre to 72 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
Measured: Ocular-motor function will be assessed at pre- and 72 hour post-heading
Acute change in autonomic nerve function from pre to 2 hour post-heading
Participants will undergo cold-pressor testing (CPT). CPT is a general assessment of the ability of the sympathetic nervous system to become activated. This test will be performed by submerging a participant's hand into cold water for 2 minutes while autonomic and hemodynamic variables are recorded. At each data collection, participants will be instrumented for the measurement of heart rate (electrocardiogram) and continuous blood pressure. Participants will rest quietly for ~10mins before the CPT begins. The test takes 2 minutes.
Mean arterial pressure (in mm/Hg) is the outcome measure.
Measured: Autonomic response will be assessed at pre- and 2 hour post-heading
Acute change in autonomic nerve function from pre to 24 hour post-heading
Participants will undergo cold-pressor testing (CPT). CPT is a general assessment of the ability of the sympathetic nervous system to become activated. This test will be performed by submerging a participant's hand into cold water for 2 minutes while autonomic and hemodynamic variables are recorded. At each data collection, participants will be instrumented for the measurement of heart rate (electrocardiogram) and continuous blood pressure. Participants will rest quietly for ~10mins before the CPT begins. The test takes 2 minutes.
Mean arterial pressure (in mm/Hg) is the outcome measure.
Measured: Autonomic response will be assessed at pre- and 24 hour post-heading
Acute change in autonomic nerve function from pre to 72 hour post-heading
Participants will undergo cold-pressor testing (CPT). CPT is a general assessment of the ability of the sympathetic nervous system to become activated. This test will be performed by submerging a participant's hand into cold water for 2 minutes while autonomic and hemodynamic variables are recorded. At each data collection, participants will be instrumented for the measurement of heart rate (electrocardiogram) and continuous blood pressure. Participants will rest quietly for ~10mins before the CPT begins. The test takes 2 minutes.
Mean arterial pressure (in mm/Hg) is the outcome measure.
Measured: Autonomic response will be assessed at pre- and 72 hour post-heading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start30 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keisuke Kawata, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641832
- Sponsor's protocol ID
- 2006187939
- Status last verified
- Feb 2023
- First submitted
- 18 Nov 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data will be included in publications.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Cannabis Use on Neural Response to Acute Subconcussive Head Impacts
- ClinicalTrials.gov ID
- NCT04641832
- Acronym / sponsor ID
- 2006187939
- Conditions
- Concussion, Mild
- Keywords
- soccer heading, subconcussive head impacts, cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Nov 2020 (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 purpose of this pilot study is to better understand the effects of chronic cannabis (THC) use on the neural responses to subconcussive head impacts, as a form of repetitive soccer headings. The study is designed to identify the physiological changes of cannabis using cohort (THC) and compare it to a nonusing cohort in order to see if the responses to 20 controlled bouts of soccer headings are exacerbated by the chronic cannabis use, diminished to less of a response, or unchanged, through an array of neurologic measures, including cognitive function, ocolar-motor function, autonomic function, and blood biomarkers. The hypothesis is that repetitive subconcussive head impacts will impair cognitive function in worse memory, attention span, and visual and verbal problem solving; this impairment will be greater in the chronic cannabis use groups than non-using group. The blood and salivary biomarkers neurofilament light (NFL) and glial fibrillary acidic protein (GFAP) will be measured in plasma, with the hypothesis that repetitive subconcussive head impacts will significantly increase plasma NFL and GFAP level at 24 hours-post heading and decrease by 72 hours-post heading, while remaining undetectable at 2 hours-post heading; the chronic cannabis use groups will see more severe effects on ocular-motor function than the non-using group. The study aims to determine the differences in acute effects of subconcussive head impacts on eye movement, attention, and language function between chronic cannabis use subjects and non-using subjects by evaluating ocular-motor function with near point of convergence and King-Devick tests. The hypothesis is that repetitive subconcussive head impacts will significantly increase impairments of eye movements, attention, and language function, as well as near point of convergence; the chronic cannabis use groups will see more severe effects on hampered ocular-motor function than the non-using group. Lastly, there is a cold pressor test to assess autonomic nerve function, with the hypothesis that repetitive subconcussive head impacts will decrease autonomic nerve function in chronic cannabis use patients to a greater degree than non-using subjects.
Detailed description
NUMBER OF PEOPLE TAKING PART IN THE STUDY
We plan to recruit 45 THC using subjects and 45 non-using subjects.
PROCEDURES FOR THE STUDY
Participants will be assigned to the THC cannabis user group or the nonuser group based on participants' report of past cannabis use. These groups will then be verified using saliva and urine tests for cannabis use history.
The study consists of 4 test sessions during a 4-day period. The 1st day will take approximately 4 hours. The 2nd and 4th day will each take approximately 1 hour. Participants will not need to do anything on the 3rd day.
- The 1st test session takes place right before the soccer heading intervention.
- After the 1st test session, participants will then perform 20 soccer headings in 10 minutes.
- The 2nd test session takes place 2h after the intervention.
- The 3rd test session takes place approximately 24h after the intervention.
- The 4th test session takes place approximately 72h after the intervention.
During each test session, participants will be asked to complete a paper-pencil questionnaire assessing participants' current feeling. The questionnaire consists of 22 possible symptoms with 7-point scale to see if participants are experiencing concussion-related symptoms. A trained phlebotomist will draw blood from a vein in participants' arm at the four time points described in the above bulletpoints. Each 4mL blood sample is equivalent to approximately 1 teaspoon. A total of approximately 16mL (3-4 teaspoons) will be drawn during this study. The researchers will collect saliva samples (2mL) at each time point. Participants will be then asked to perform eye-movement tasks with directions from the research assistant. The eye-movement tasks consist of watching an object nearing the face (called a convergence test) and a brief test that asks participants to name numbers aloud from a screen. These eye-movement tasks will be repeated twice and will take about 2 minutes. After eye-movement testing, the investigators will ask participants to complete an imPACT test, which is a computerized test commonly used to diagnose concussions that measures memory, attention span, and visual and verbal problem solving. Completing the imPACT takes 20 to 25min. The last test is an autonomic function test, where participants will place participants' hand in a bowl of ice water for 60s while participants' heartrate is recorded.
The first 1st test session is slightly longer than the other two. It requires a saliva collection, where participants are asked to collect saliva in his/her mouth for approximately 15s before spitting onto a test strip. Researchers will need to collect about 7mL (1.5 teaspoon) of saliva from participants. This test will verify that participants have not used cannabis products in the past 72 hours. participants will also be asked for a urine sample. A urine sample of approximately 50mL will be used to verify cannabis use history over the past 3 months.
During the 1st day, after finishing the 1st test session, participants will perform 20 soccer headings. A standard size 5 soccer ball will be projected at 25 mph (equivalent speed to a long throw-in) by a JUGS soccer machine, and participants will perform 20 headers with 30 seconds resting period between each header. participants will be asked to direct the ball back towards the JUGS soccer machine in the air.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic cannabis use and subconcussive head impacts | Experimental | Other: Soccer headingGroup: Chronic cannabis users Criteria: self-reported chronic THC use (average use once per week but not dependent). Urine cannabis test must show positive. Device: Soccer Heading Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 20 consecutive soccer headings, separated by one minute intervals. |
| Non-cannabis use and subconcussive head impacts | Active comparator | Other: Soccer headingGroup: Non cannabis users Criteria: self-reported none THC use. Urine cannabis test must show negative. Device: Soccer Heading Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 20 consecutive soccer headings, separated by one minute intervals. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- For Chronic THC User Group
- being between 18 to 26 years of age
- self-reported chronic THC use (average use once per week but not dependent)3) at least 3 years of soccer heading experience.
- For Non-User Cohort
- being between 18 to 26 years of age
Key exclusion criteria (15 listed)
- any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
- history of vestibular, ocular, or vision dysfunction (e.g., macular degeneration)
- currently taking any medications affecting balance (e.g., antibiotics)
- pregnancy
- HIV
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 |
|---|---|---|
| Soccer headingA standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 standing headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air. | Other | Chronic cannabis use and subconcussive head impacts, Non-cannabis use and subconcussive head impacts |
Primary outcome
Acute change in brain-derived blood and saliva biomarkers from pre to 24 hour post-heading
Time frame: Blood samples will be collected at pre- and 24 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis. Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Acute change in brain-derived blood and saliva biomarkers from pre to 2 hour post-heading
Time frame: Blood and saliva samples will be collected at pre- and 2 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis. Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Acute change in neurocognitive function from pre to 2 hour post-heading
Time frame: Neurocognitive function will be assessed at pre- and 2 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Acute change in neurocognitive function from pre to 24 hour post-heading
Time frame: Neurocognitive function will be assessed at pre- and 24 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Acute change in ocular-motor function from pre to 2 hour post-heading
Time frame: Ocular-motor function will be assessed at pre- and 2 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
Acute change in ocular-motor function from pre to 24 hour post-heading
Time frame: Ocular-motor function will be assessed at pre- and 24 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
6 secondary outcomes
Acute change in brain-derived blood and saliva biomarkers from pre to 72 hour post-heading
Time frame: Blood and saliva samples will be collected at pre- and 72 hour post-heading
Acute change in neurocognitive function from pre to 72 hour post-heading
Time frame: Neurocognitive function will be assessed at pre- and 72 hour post-heading
Acute change in ocular-motor function from pre to 72 hour post-heading
Time frame: Ocular-motor function will be assessed at pre- and 72 hour post-heading
Acute change in autonomic nerve function from pre to 2 hour post-heading
Time frame: Autonomic response will be assessed at pre- and 2 hour post-heading
Acute change in autonomic nerve function from pre to 24 hour post-heading
Time frame: Autonomic response will be assessed at pre- and 24 hour post-heading
Acute change in autonomic nerve function from pre to 72 hour post-heading
Time frame: Autonomic response will be assessed at pre- and 72 hour post-heading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No. All study data will be included in publications.
Related trials for Concussion, Mild
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer heading in people with Concussion, Mild, run by Indiana 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 2 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in brain-derived blood and saliva biomarkers from pre to 24 hour post-heading (time frame: Blood samples will be collected at pre- and 24 hour post-heading). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.