NCT03863639

Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia

A Pilot Study to Assess fMRI Changes and Neurocognitive Function in Women With Pre-eclampsia

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a pilot study assessing fMRI changes and neurocognitive function in women with pre-eclampsia and healthy controls. Neurocognitive testing will be done during pregnancy and after delivery up to 2-6 weeks postpartum. fMRI will be done after delivery up to 2-6 weeks postpartum. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population.

Conditions

• Pre-Eclampsia
• Neurocognitive Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Neuroimaging Procedures	Subjects will complete neuroimaging procedures at 2-6-week postpartum or during hospitalization after delivery prior to discharge, which will consist of high-resolution anatomic, perfusion and resting-brain fMRI sequences; all of which will be acquired on a 3-Tesla General Electric magnetic resonance scanner provided by the Brain Imaging and Analysis Center (BIAC) at Duke University. No contrast agent will be administered in these imaging procedures.
DIAGNOSTIC_TEST	Neuropsychological Assessment Procedures	Once identified as meeting study criteria and consented for participation, parturients will be tested during hospitalization or as outpatients for controls, and at 2-6 weeks postpartum with the following cognitive battery. Wechsler Test of Adult Reading (WTAR), CANTABeclipse Computerized Cognitive Assessment Measures, Stroop Color-Word Test, Controlled Oral Word Association Test, EuroQol, Beck Depression Inventory Revised

Timeline

• Start date: 2014-07-07
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2019-03-05
• Last updated: 2022-06-29

Locations

1 site across 1 country: United States