212 Participants Needed

Modalities for Healthy Subjects

SK
Overseen BySarah Kucker, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Oklahoma State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Modalities for Healthy Subjects?

The research on multimodality imaging systems suggests that combining different imaging techniques can improve diagnostics and therapeutic monitoring by integrating the strengths of each modality. This implies that the treatment modalities being studied may offer enhanced diagnostic and therapeutic capabilities by leveraging the benefits of both 2D and 3D imaging.12345

Is the treatment generally safe for humans?

Gadolinium-based contrast agents, used in MRI scans, have been widely used for 30 years and are generally considered safe, though there have been reports of gadolinium remaining in the brain without known harmful effects. Some people may experience mild reactions, but serious adverse events are rare.678910

What is the purpose of this trial?

The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: 3D-2DExperimental Treatment1 Intervention
Initial exposure to items in 3D, generalization in 2D
Group II: 2D-3DExperimental Treatment1 Intervention
Initial exposure to items in 2D, generalization in 3D
Group III: 2D-2DExperimental Treatment1 Intervention
Initial exposure to items in 2D, generalization in 2D
Group IV: 3D-3DActive Control1 Intervention
All items presented in 3D form.

Find a Clinic Near You

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+

Findings from Research

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

References

Mn doped Prussian blue nanoparticles for T1/T2 MR imaging, PA imaging and Fenton reaction enhanced mild temperature photothermal therapy of tumor. [2022]
Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design. [2019]
The impact of registration accuracy on imaging validation study design: A novel statistical power calculation. [2019]
MRI Radiomic Features: Association with Disease-Free Survival in Patients with Triple-Negative Breast Cancer. [2021]
Multimodality in vivo imaging systems: twice the power or double the trouble? [2006]
Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]
Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. [2016]
Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. [2019]
Methodological Aspects for Preclinical Evaluation of Gadolinium Presence in Brain Tissue: Critical Appraisal and Suggestions for Harmonization-A Joint Initiative. [2019]
10.United Statespubmed.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. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security