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NCT04641832 · ClinicalTrials.gov registry record · NA
The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health
A NA study of Concussion, Mild, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04641832: Completed NA study of Concussion, Mild, sponsored by Indiana University.
NCT04641832 is a NA study of Concussion, Mild that has completed, run by Indiana University. The registered enrollment target is 70 participants, below the 200-participant average among 18 other Concussion, Mild trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04641832, a NA study of Concussion, Mild, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Soccer heading
Study Locations (1)
Indiana
- Indiana University School of Public Health - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2021-12-01 |
| Phase | NA |
What the finished NCT04641832 record still lists
NCT04641832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 200-participant average among 18 other Concussion, Mild trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Concussion, Mild appearing as the primary indexed condition, and to 1 intervention - of which Soccer heading is the first listed.
NCT04641832 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04641832 about?
NCT04641832 is a clinical study titled "The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health". 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 ...
What is the current status of trial NCT04641832?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2020-10-30. Estimated completion is 2021-12-01.
What conditions does trial NCT04641832 study?
This clinical trial studies the following conditions: Concussion, Mild.
What interventions are being tested in trial NCT04641832?
The interventions under investigation include: Soccer heading (OTHER).
Who is sponsoring clinical trial NCT04641832?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04641832 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04641832's enrollment target sits among peer trials
70 13th of 18 higher than 6 of 18 other Concussion, Mild trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion, Mild trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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