The Biomarkers of Neurological Disease in Utero Study (BONDING)
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|ClinicalTrials.gov Identifier: NCT04043572|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 8, 2020
Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus. Particular risks include congenital malformations, impaired motor and cognitive functioning, autism and poorer educational attainment. Fetal exposure to drugs that bind to central nervous system targets as part of their therapeutic effect (e.g. neurotransmitter receptors and neuronal channels) appear to alter brain structure and function in both animal models and humans.
Fetal magnetic resonance imaging offers an approach to investigate these effects in vivo, identifying biomarkers, defining the onset of abnormalities and dose response. Fetal MRI may offer risk stratification and identify patients that may benefit from intervention early in development. The overall aim of this study is to contribute to improving developmental outcomes following the inevitable exposure during treatment of maternal epilepsy.
This novel study aims to explore the central nervous system with state-of-the-art non-invasive multimodal magnetic resonance imaging consistent with the University of Nottingham Precision Imaging Beacon, so as to improve outcomes in patients at risk of long term complex neuropsychiatric conditions.
|Condition or disease|
|Epilepsy Neurodevelopmental Disorders Fetal Disease Teratogenesis|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||The Biomarkers of Neurological Disease in Utero Study|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||October 2025|
Participants with Epilepsy
This group comprises pregnant patients with epilepsy who are actively using anti-epileptic drugs
- Using in utero MRI, can we detect abnormal structural brain development in fetuses exposed to anti-epileptic drugs compared to healthy controls. [ Time Frame: 60 months ]To use volume reconstructed MRI data to measure volumetric changes (in mm cubed) in brain parenchyma substructures in cases of anti-epileptic drug exposed and healthy fetuses.
- Using in utero diffusion MRI, can we detect abnormal brain connectivity in fetuses exposed to anti-epileptic drugs compared to healthy controls. [ Time Frame: 60 months ]To use motion-corrected diffusion MRI data to assess white matter connectivity as determined by changes in fractional anisotropy, apparent diffusion coefficient, and tractography.
- Using in utero functional MRI, can we detect abnormal brain blood-oxygen (BOLD) dependant signal in fetuses exposed to anti-epileptic drugs compared to healthy controls. [ Time Frame: 60 months ]To use motion-correct functional MRI to determine changes in the resting state network as determined by measuring BOLD signal activation.
- Using in utero cine MRI, can we detect abnormal motor behaviour in fetuses exposed to anti-epileptic drugs compared to healthy controls. [ Time Frame: 60 months ]To use General Movement analysis to detect abnormal patterns of motor behaviour in fetuses as compared to healthy controls.
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): NCT04043572
|Contact: Tayyib T Hayat, MRCP PhDfirstname.lastname@example.org|
|Nottingham University Hospitals NHS Trust||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Contact: Tayyib T Hayat, MRCP PhD|
|Principal Investigator: Tayyib T Hayat, MRCP PhD|
|Study Chair:||Tayyib T Hayat, MRCP PhD||Nottingham University Hospitals NHS Trust|