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Completed

NCT Number: NCT04817059

Reducing Head Motion With Customized Head Mold in Young Children

The purpose of this study is to assess the safety and efficacy of a customized head mold for reducing head motion during MRI scanning in young children.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Discovery Building Biomedical Imaging Center

Austin, Texas, 78712, United States

About this study

Each participant completed a dedicated session for mock scanning before we acquired two sets of sMRI and fMRI scans. One scan set was collected using the head mold and the other without, and the scans were counterbalanced in order across participants. Using a specialized sMRI sequence embedded with vNAVs, we directly measured head motion during sMRI in order to more accurately evaluate the head mold's impact on structural metrics. To evaluate the feasibility and tolerability of the head mold, we concluded the scanning sessions with a brief interview that gauged participants' scanning experience and tolerance of the head mold. We investigated whether head molds would reduce head motion compared to standard scanning procedures and whether those reductions would result in improved data quality. We also tested the extent to which reductions in head motion impacted estimations of cortical volume and functional connectivity. Prior to data collection, we evaluated the noise dosage levels of the head mold condition, given the limited space available for additional hearing protection devices in the head coil while the head mold is on. We also assessed whether the head molds could balance head motion between typical and ADHD populations, and whether clinical variables such as ADHD diagnosis and trait anxiety, as determined by parent-reported dimensional measures, can predict head mold efficacy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between ages 5 - 10
  • ADHD diagnosis as determined by parent self-report

Exclusion criteria

  • no MRI contraindications and no history of head injuries or seizures.

Treatment and study plan

Caseforge headcase

Device

We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.

Primary outcomes

  1. Head motion during MRI scanning

    Time frame: during MRI scanning

    Head motion during MRI scanning was estimated and compared with and without the head mold on.

Secondary outcomes

  1. Image quality

    Time frame: during MRI scanning

    MRI quality was also compared between experimental and control conditions.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

The Impact of Customized Head Molds on Motion and Motion-related Artifacts From Structural and Functional MRI Scans in Children

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2021
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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