Reducing Head Motion With Customized Head Mold in Young Children

Adhd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817059
• Other study ID #: Robust Motion
• Status: Completed
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: March 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhd
• Child Development
• Neuroimag

Intervention

Device:
• Caseforge headcase
We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.

Locations

Country	Name	City	State
United States	Health Discovery Building Biomedical Imaging Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head motion during MRI scanning	Head motion during MRI scanning was estimated and compared with and without the head mold on.	during MRI scanning
Secondary	Image quality	MRI quality was also compared between experimental and control conditions.	during MRI scanning