Reducing Head Motion With Customized Head Mold in Young Children

Not Applicable

Completed

• Conditions: Child Development; Adhd; Neuroimag

• Registration Number: NCT04817059
• Lead Sponsor: University of Texas at Austin

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Image quality	during MRI scanning	MRI quality was also compared between experimental and control conditions.

Trial Locations

Locations (1)

Health Discovery Building Biomedical Imaging Center; 🇺🇸 Austin, Texas, United States