Modalities for Healthy Subjects

Overseen By Sarah Kucker, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Disqualifiers: Developmental delay, Other language exposure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how young children learn new words through digital media. Researchers test different ways of presenting information, such as showing items in 2D or 3D (referred to as Modality - 2D-2D, Modality - 2D-3D, and Modality - 3D-2D), to assess their impact on vocabulary development. The goal is to identify the best methods for teaching kids words using screens. Children aged 18-30 months, who have not been diagnosed with developmental delays and are primarily exposed to one language, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective digital learning methods for young children.

Do I need to stop my child's current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that these modalities are safe for young children?

Research shows that the treatments under study—Modality - 2D-2D, Modality - 2D-3D, and Modality - 3D-2D—are generally well-tolerated by healthy individuals. Sources indicate that any side effects are expected to be minor and temporary.

For the 2D-3D treatment, studies on similar imaging techniques, such as those used in MRI (magnetic resonance imaging), suggest minimal long-term risk. Any effects from such imaging are usually minor and resolve on their own.

For the 2D-2D and 3D-2D treatments, sources also suggest these methods are safe for healthy individuals, with manageable side effects. No reports of serious adverse events have been linked to these treatments.

In summary, existing research supports the safety of these treatments for healthy individuals, indicating they are unlikely to cause significant harm. However, participants should remain informed about any safety updates as the trial progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the different modalities being explored in this trial because they aim to understand how presenting information in various formats can impact learning and generalization. Unlike traditional learning methods that often rely on static, two-dimensional (2D) presentations, these modalities incorporate three-dimensional (3D) exposures to potentially enhance comprehension and memory retention. Specifically, the 2D-3D and 3D-2D modalities leverage the transition between 2D and 3D perspectives, which could provide insights into how dimensional context affects cognitive processing. By examining these different approaches, researchers hope to uncover more effective strategies for educational and therapeutic applications, potentially transforming how information is conveyed across various fields.

What evidence suggests that this trial's modalities could be effective for word learning in digital environments?

Research shows that different digital tools can affect how children, especially young ones, learn. This trial will compare various modalities, including 2D-2D, 2D-3D, 3D-2D, and 3D-3D, to evaluate their effectiveness. Studies have found that 3D learning tools often surpass 2D ones in teaching complex topics. The engaging nature of 3D tools can lead to better word learning and vocabulary skills. Additionally, combining 2D and 3D methods can help children apply their learning in various situations. Early findings suggest these digital tools can enhance learning without major side effects. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy toddlers aged between 17 to 30 months. It's designed for those who primarily speak one language and have not been diagnosed with any developmental delays or disorders.

Inclusion Criteria

My child is between 17 and 30 months old.

Exclusion Criteria

You have been diagnosed with a delay or disorder in your development.

You are not fluent in the study's required language, and have been exposed to more than 25% of another language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in tasks to test word learning and generalization abilities using digital media

4-6 weeks

Follow-up

Participants are monitored for vocabulary growth and retention after the tasks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modality - 2D-2D
• Modality - 2D-3D
• Modality - 3D-2D

Trial Overview

The study explores how toddlers learn new words through different types of digital media exposure: from two-dimensional (2D) to two-dimensional, three-dimensional (3D) to two-dimensional, and two-dimensional to three-dimensional formats.

How Is the Trial Designed?

Group I: 3D-2D Experimental Treatment 1 Intervention

Initial exposure to items in 3D, generalization in 2D

Group II: 2D-3D Experimental Treatment 1 Intervention

Initial exposure to items in 2D, generalization in 3D

Group III: 2D-2D Experimental Treatment 1 Intervention

Initial exposure to items in 2D, generalization in 2D

Group IV: 3D-3D Active Control 1 Intervention

All items presented in 3D form.

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study of 863 patients undergoing MRI with gadodiamide contrast, only 9 reported mild adverse events, all of which were from the group that was actively questioned about their experiences after the injection.

The results suggest that the frequency of reported adverse events is influenced by whether patients are actively asked about them, indicating that many mild reactions may go unreported without such inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. Thomsen, HS.[2019]

Mn-doped Prussian blue nanoparticles (MnPB NPs) show strong potential for enhancing both imaging and treatment of tumors, demonstrating excellent performance in T1 and T2 weighted MRI and effective photothermal therapy due to their near-infrared absorbance.

The integration of multimodal imaging with chemodynamic therapy (CDT) and mild temperature photothermal therapy (PTT) using MnPB NPs significantly improves therapeutic efficacy, making them a promising tool for simultaneous diagnosis and treatment of tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mn doped Prussian blue nanoparticles for T1/T2 MR imaging, PA imaging and Fenton reaction enhanced mild temperature photothermal therapy of tumor. Tao, Q., He, G., Ye, S., et al.[2022]

In a study involving 17,767 patients across 45 European centers, only 30 acute adverse reactions (0.17%) were reported after administering gadolinium-based contrast agents during cardiac magnetic resonance imaging, all classified as mild.

The most common reactions included rashes, hives, nausea, and anxiety, with the incidence of adverse events being comparable to that seen in general radiology settings, indicating that the off-label use of these agents in CMR is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. Bruder, O., Schneider, S., Nothnagel, D., et al.[2016]

Gadolinium-based contrast agents (GBCAs) have been safely used for 30 years, providing significant clinical benefits, but recent studies have shown unexpected long-term retention of gadolinium in the brain, particularly with linear GBCAs compared to macrocyclic GBCAs.

While no clinical consequences of gadolinium presence in the brain have been confirmed, further research is essential to understand the potential toxicological effects and to refine the clinical use of GBCAs, similar to past adaptations made during the nephrogenic systemic fibrosis crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Aspects for Preclinical Evaluation of Gadolinium Presence in Brain Tissue: Critical Appraisal and Suggestions for Harmonization-A Joint Initiative. Robert, P., Frenzel, T., Factor, C., et al.[2019]

In a study of 154,779 patients undergoing cardiac MRI, gadolinium-based contrast agents (GBCAs) were used in 94.2% of cases, with a significant shift towards macrocyclic agents following regulatory changes, which showed a favorable acute safety profile.

The overall rate of acute adverse events (AAEs) associated with GBCAs was low at 0.36%, with severe events occurring in only 0.03% of patients, indicating that GBCAs, particularly macrocyclic types, are generally safe for use in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. Uhlig, J., Al-Bourini, O., Salgado, R., et al.[2022]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

Advanced imaging techniques in oncology have not been widely accepted for guiding treatment decisions or improving clinical trial efficiency due to insufficient evidence supporting their effectiveness.

The paper highlights the need for better study designs and statistical methods to evaluate advanced imaging, emphasizing that merely showing a correlation between imaging results and clinical outcomes is not enough to prove their utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design. Huang, EP., Lin, FI., Shankar, LK.[2019]

A study involving 228 triple-negative breast cancer (TNBC) patients developed a radiomics score from MRI features that significantly predicts disease-free survival (DFS), showing worse DFS associated with higher scores in both training and validation sets.

The combined clinicopathologic-radiomic (CCR) model outperformed traditional clinicopathologic models in predicting DFS, indicating that integrating MRI-based radiomic features can enhance prognostic accuracy for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI Radiomic Features: Association with Disease-Free Survival in Patients with Triple-Negative Breast Cancer. Kim, S., Kim, MJ., Kim, EK., et al.[2021]

Multimodality imaging systems combine different types of radiation to enhance diagnostic capabilities by leveraging the strengths of each imaging technique while minimizing their weaknesses.

These advanced imaging systems are already being used in clinical settings and research, providing improved diagnostics and therapeutic monitoring for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality in vivo imaging systems: twice the power or double the trouble? Cherry, SR.[2006]

The study introduces a power calculation formula that helps determine the necessary number of subjects and acceptable registration error for imaging validation studies, which is crucial for accurately assessing novel imaging modalities.

Monte Carlo simulations confirmed that the derived models can predict study power and minimum detectable differences with high accuracy, providing a valuable tool for designing effective imaging studies, such as those for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of registration accuracy on imaging validation study design: A novel statistical power calculation. Gibson, E., Fenster, A., Ward, AD.[2019]

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Modalities for Healthy Subjects · Info for Participants

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