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NCT04880304 · ClinicalTrials.gov registry record · NA
Effects of Subconcussive Head Impacts on Neural Integrity and Function in ADHD
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT04880304 is a NA study that has completed, run by Indiana University. The registered enrollment target is 69 participants.
The verdict
NCT04880304, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the acute neural responses to subconcussive head impacts in individuals with Attention-deficit/hyperactivity disorder (ADHD). The study is designed to identify the effects of 10 controlled soccer headings in college-aged soccer players diagnosed with ADHD and without ADHD, through the use of neural-injury blood biomarkers, functional and diffusion MRI, and ocular-motor function across three acute timepoints. The central hypothesis is that neuronal structural, physiological, and functional impairments from subconcussive head impacts will be amplified by ADHD. The neural-injury blood biomarkers neurofilament light (NF-L), glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase-L1 (UCHL-1), and Tau will be measured in plasma, with the hypothesis that 10 soccer headings will significantly increase plasma NF-L levels in both groups at 24h post-heading compared to baseline, but this increase will be higher in the ADHD group; plasma UCH-L1, GFAP, and Tau levels will increase significantly after 10 headings in the ADHD group at 2h and 24h post-heading, but levels in the non-ADHD group will remain consistent throughout the time points. It is also hypothesized that repetitive subconcussive head impacts will impair neurocognitive function, as measured by regional changes in fMRI activation during working memory and attention-based tasks, in the ADHD group. Ten headings will significantly alter fMRI activation in the ADHD group from baseline. This impairment will not be observed in the non-ADHD group, rather the non-ADHD group will show consistent fMRI activation even after 10 headings. White matter microstructure will be measured by diffusion imaging metrics, with the hypothesis that 10 soccer headings will significantly disrupt microstructure in the ADHD group compared to baseline, but not in the non-ADHD group. The study will also assess neuro-ophthalmologic function as measured by the King-Devick test (KDT) and oculomot
Interventions
- OTHER Soccer Heading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2022-03-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04880304
The ClinicalTrials.gov registry entry for NCT04880304 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Soccer Heading is the first listed.
NCT04880304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04880304 about?
NCT04880304 is a clinical study titled "Effects of Subconcussive Head Impacts on Neural Integrity and Function in ADHD". The purpose of this study is to examine the acute neural responses to subconcussive head impacts in individuals with Attention-deficit/hyperactivity disorder (ADHD). The study is designed to identify the effects of 10 controlled soccer headings in college-aged soccer players diagnosed with ADHD and ...
What is the current status of trial NCT04880304?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2021-03-15. Estimated completion is 2022-03-15.
What interventions are being tested in trial NCT04880304?
The interventions under investigation include: Soccer Heading (OTHER).
Who is sponsoring clinical trial NCT04880304?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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