Dataset Information

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study.

ABSTRACT: Patients with hypoplastic left heart syndrome who have been palliated with the Fontan procedure are at risk for adverse neurodevelopmental outcomes, lower quality of life, and reduced employability. We describe the methods (including quality assurance and quality control protocols) and challenges of a multi-center observational ancillary study, SVRIII (Single Ventricle Reconstruction Trial) Brain Connectome. Our original goal was to obtain advanced neuroimaging (Diffusion Tensor Imaging and Resting-BOLD) in 140 SVR III participants and 100 healthy controls for brain connectome analyses. Linear regression and mediation statistical methods will be used to analyze associations of brain connectome measures with neurocognitive measures and clinical risk factors. Initial recruitment challenges occurred related to difficulties with: 1) coordinating brain MRI for participants already undergoing extensive testing in the parent study, and 2) recruiting healthy control subjects. The COVID-19 pandemic negatively affected enrollment late in the study. Enrollment challenges were addressed by 1) adding additional study sites, 2) increasing the frequency of meetings with site coordinators and 3) developing additional healthy control recruitment strategies, including using research registries and advertising the study to community-based groups. Technical challenges that emerged early in the study were related to the acquisition, harmonization, and transfer of neuroimages. These hurdles were successfully overcome with protocol modifications and frequent site visits that involved human and synthetic phantoms.

Trial registration number

ClinicalTrials.gov Registration Number: NCT02692443.

SUBMITTER: Schmithorst V

PROVIDER: S-EPMC10153324 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study.

Schmithorst Vanessa V Ceschin Rafael R Lee Vince V Wallace Julia J Sahel Aurelia A Chenevert Thomas T Parmar Hemant H Berman Jeffrey I JI Vossough Arastoo A Qiu Deqiang D Kadom Nadja N Grant Patricia Ellen PE Gagoski Borjan B LaViolette Peter P Maheshwari Mohit M Sleeper Lynn A LA Bellinger David D Ilardi Dawn D O'Neil Sharon S Miller Thomas A TA Detterich Jon J Hill Kevin D KD Atz Andrew M AM Richmond Marc M Cnota James J Mahle William T WT Ghanayem Nancy N Gaynor William W Goldberg Caren S CS Newburger Jane W JW Panigrahy Ashok A

medRxiv : the preprint server for health sciences 20230417

Patients with hypoplastic left heart syndrome who have been palliated with the Fontan procedure are at risk for adverse neurodevelopmental outcomes, lower quality of life, and reduced employability. We describe the methods (including quality assurance and quality control protocols) and challenges of a multi-center observational ancillary study, SVRIII (Single Ventricle Reconstruction Trial) Brain Connectome. Our original goal was to obtain advanced neuroimaging (Diffusion Tensor Imaging and Rest ...[more]

PMID: 37131744

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Project description:Recent advancements of multimodal neuroimaging such as functional MRI (fMRI) and diffusion MRI (dMRI) offers unprecedented opportunities to understand brain development. Most existing neurodevelopmental studies focus on using a single imaging modality to study microstructure or neural activations in localized brain regions. The developmental changes of brain network architecture in childhood and adolescence are not well understood. Our study made use of dMRI and resting-state fMRI imaging data sets from Philadelphia Neurodevelopmental Cohort (PNC) study to characterize developmental changes in both structural as well as functional brain connectomes. A multimodal multilevel model (MMM) is developed and implemented in PNC study to investigate brain maturation in both white matter structural connection and intrinsic functional connection. MMM addresses several major challenges in multimodal connectivity analysis. First, by using a first-level data generative model for observed measures and a second-level latent network modeling, MMM effectively infers underlying connection states from noisy imaging-based connectivity measurements. Secondly, MMM models the interplay between the structural and functional connections to capture the relationship between different brain connectomes. Thirdly, MMM incorporates covariate effects in the network modeling to investigate network heterogeneity across subpopoulations. Finally, by using a module-wise parameterization based on brain network topology, MMM is scalable to whole-brain connectomics. MMM analysis of the PNC study generates new insights in neurodevelopment during adolescence including revealing the majority of the white fiber connectivity growth are related to the cognitive networks where the most significant increase is found between the default mode and the executive control network with a 15% increase in the probability of structural connections. We also uncover functional connectome development mainly derived from global functional integration rather than direct anatomical connections. To the best of our knowledge, these findings have not been reported in the literature using multimodal connectomics. Supplementary materials for this article, including a standardized description of the materials available for reproducing the work, are available as an online supplement.

Dataset Information

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study.

Trial registration number

Publications

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study.

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