Reducing Head Motion With Customized Head Mold in Young Children

Study Overview
=================
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.

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

Conditions
-----------------
Child Development, Adhd, Neuroimag

Intervention / Treatment
-----------------
* Device: Caseforge headcase


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head mold on<br> | Device: Caseforge headcase<br>* We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.<br>|
| No Intervention: Head mold off<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | MRI quality was also compared between experimental and control conditions. | during MRI scanning |