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The Biomarkers of Neurological Disease in Utero Study (BONDING)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043572
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Participants with Epilepsy
This group comprises pregnant patients with epilepsy who are actively using anti-epileptic drugs
Healthy Controls
Healthy volunteers



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
The cases will be selected from the joint epilepsy-obstetrics clinical service.
Criteria

Inclusion Criteria:

Singleton pregnancy Age 18 - 45 years BMI < 50 Able to give informed consent

Exclusion Criteria:

Multiple pregnancy Age less than 18 or greater than 45 years old BMI > 50 Unable to give informed consent Contraindication to MRI Refractory seizures Seizure(s) within last 30 days Unstable for transfer to MRI


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): NCT04043572


Contacts
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Contact: Tayyib T Hayat, MRCP PhD +447971903513 tayyib.hayat@nottingham.ac.uk

Locations
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United Kingdom
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         
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
University of Nottingham
Investigators
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Study Chair: Tayyib T Hayat, MRCP PhD Nottingham University Hospitals NHS Trust
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04043572    
Other Study ID Numbers: 19OB002
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nottingham University Hospitals NHS Trust:
Fetus
Neurological Development
Teratogenicity
Anti-Epileptic Drugs
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Nervous System Diseases
Fetal Diseases
Teratogenesis
Neurodevelopmental Disorders
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Pregnancy Complications
Pathologic Processes