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Reducing Head Motion With Customized Head Mold in Young Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817059
Recruitment Status : Completed
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Child Development Adhd Neuroimag Device: Caseforge headcase Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Customized Head Molds on Motion and Motion-related Artifacts From Structural and Functional MRI Scans in Children
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Head mold on Device: Caseforge headcase
We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.
No Intervention: Head mold off


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Image quality [ Time Frame: during MRI scanning ]
    MRI quality was also compared between experimental and control conditions.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817059


Locations
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United States, Texas
Health Discovery Building Biomedical Imaging Center
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Cameron Craddock, PhD University of Texas at Austin
More Information
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04817059    
Other Study ID Numbers: Robust Motion
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All data will be de-identified using standards conforming to HIPAA guidelines. Consistent with the model setup by the International Data Sharing Initiative (INDI) effort, data will be distributed via the NITRC-based Functional Connectome Project (FCP)/INDI website (http://fcon_1000.projects.nitrc.org/). The following steps will be carried out to ensure that no identifying or protected health information is released:

  • All imaging files will be stripped of fields containing protected health information, and date of exam will be removed
  • Anatomical images will have face information removed or obscured.
  • Random ID numbers will be generated and assigned to each dataset prior to release.

Legal guardians of the child participants will be asked if they consent to having their data shared publicly, as well as privately with other University of Texas at Austin researchers. If they do not consent to having their data shared, they may still participate in the study without penalty.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No