Reducing Head Motion With Customized Head Mold in Young Children

NCT ID: NCT04817059

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2019-08-08

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.

Conditions

Child Development; Adhd; Neuroimag

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Head mold on

Group Type: EXPERIMENTAL

Caseforge headcase

Intervention Type: DEVICE

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

Head mold off

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caseforge headcase

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cameron Craddock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Health Discovery Building Biomedical Imaging Center

Austin, Texas, United States

Countries

United States

Other Identifiers

Robust Motion

Identifier Type: -

Identifier Source: org_study_id