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The Biomarkers of Neurological Disease in Utero Study

NCT04043572 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

  • Epilepsy
  • Neurodevelopmental Disorders
  • Fetal Disease
  • Teratogenesis

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Tayyib T Hayat, MRCP PhD · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04043572 on ClinicalTrials.gov