Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04641832
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2020-11-18
Brief Title:
The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
The Effect of Chronic Cannabis Use on Neural Response to Acute Subconcussive Head Impacts
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 hisher mouth for approximately 15s before spitting onto a test strip Researchers will need to collect about 7mL 15 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
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 hisher mouth for approximately 15s before spitting onto a test strip Researchers will need to collect about 7mL 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None