Child DevelopmentNCT04817059
Reducing Head Motion With Customized Head Mold in Young Children
A study testing Caseforge headcase in people with Child Development and Adhd, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Adhd, Neuroimag
- What is being tested?
- Caseforge headcase
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- between ages 5 - 10
- ADHD diagnosis as determined by parent self-report
Who cannot join
- no MRI contraindications and no history of head injuries or seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Discovery Building Biomedical Imaging Center
Austin, Texas, 78712
About this study
Official title: The Impact of Customized Head Molds on Motion and Motion-related Artifacts From Structural and Functional MRI Scans in Children
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.
Read the 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
- Being tested
- Caseforge headcase
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caseforge headcaseDevice
We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.
| Study group | Role | What they receive |
|---|---|---|
| Head mold on | Experimental | Not described Receives: Device: Caseforge headcase |
| Head mold off | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head motion during MRI scanning
Head motion during MRI scanning was estimated and compared with and without the head mold on.
Measured: during MRI scanning
Secondary outcomes (1)
Image quality
MRI quality was also compared between experimental and control conditions.
Measured: during MRI scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start19 Jun 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron Craddock, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817059
- Sponsor's protocol ID
- Robust Motion
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Customized Head Molds on Motion and Motion-related Artifacts From Structural and Functional MRI Scans in Children
- ClinicalTrials.gov ID
- NCT04817059
- Acronym / sponsor ID
- Robust Motion
- Conditions
- Child Development, Adhd, Neuroimag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head mold on | Experimental | Device: Caseforge headcase |
| Head mold off | No intervention | – |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- between ages 5 - 10
- ADHD diagnosis as determined by parent self-report
Key exclusion criteria (1 listed)
- no MRI contraindications and no history of head injuries or seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caseforge headcaseWe used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning. | Device | Head mold on |
Primary outcome
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.
1 secondary outcome
Image quality
Time frame: during MRI scanning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron Craddock, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caseforge headcase in people with Child Development and Adhd, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head motion during MRI scanning (time frame: during MRI scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.