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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: Completed NA study, sponsored by Indiana University.

NCT04880304 is a NA study that has completed, run by Indiana University. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum samples will be aliquoted and stored at -80 degree celsius until analysis. Serum samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), tau, and Ubiquitin C-terminal Hydrolase 1 (UCH-L1). All expression levels in pg/mL.

Interventions

  • OTHER Soccer Heading

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2021-03-15
Est. Completion 2022-03-15
Phase NA
Indiana University

890 total trials

What the finished NCT04880304 record still lists

NCT04880304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Soccer Heading is the first listed.

NCT04880304 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04880304's enrollment target sits among peer trials

69 1133rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04880304, the US trial registry maintained by the National Library of Medicine. NCT04880304 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.