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

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.

Study Overview

• Status: Terminated
• Conditions: Pre-Eclampsia; Neurocognitive Dysfunction
• Intervention / Treatment: Diagnostic test: Neuroimaging Procedures; Diagnostic test: Neuropsychological Assessment Procedures

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Parturients with severe pre-eclampsia on the labor and delivery ward and healthy controls presenting to the antenatal clinic or the labor ward will be screened. 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.

Description

Inclusion Criteria:Severe Pre-Eclampsia defined by

• Symptoms of central nervous system dysfunction (New onset cerebral or visual disturbance, such as: Photopsia, scotomata, cortical blindness, retinal vasospasm)
• Severe headache (ie, incapacitating, "the worst headache I've ever had") or headache that persists and progresses despite analgesic therapy
• Altered mental status
• Hepatic abnormality (Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by an alternative diagnosis or serum transaminase concentration ≥ twice normal, or both)
• Severe blood pressure elevation (Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on two occasions at least four hours apart while the patient is on bedrest (unless the patient is on antihypertensive therapy))
• Thrombocytopenia (<100,000 platelets/microL)
• Renal abnormality (Progressive renal insufficiency (serum creatinine >1.1 mg/dL or doubling of serum creatinine concentration in the absence of other renal disease))

• Pulmonary edema

  15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.

Exclusion Criteria:

• History of symptomatic cerebrovascular disease with substantial residual deficit
• History of alcoholism
• History of psychiatric illness
• History of claustrophobia
• Renal failure (creatinine > 2.0 mg/dl)
• Patients with less than a 7th grade education or unable to read and thus unable complete the neuropsychological testing
• Patients with bodily implants unsafe for MRI use

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Eclampsia; 15 English-speaking women with severe pre-eclampsia	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
Control; 15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of white matter lesions	DTI white matter patency in women with pre-eclampsia/eclampsia.	Postpartum (2-6 weeks or while hospitalized)
Classification of white matter lesions	Classify the nature of co-morbid DTI white matter patency/lesions	Postpartum (2-6 weeks or while hospitalized)
Neurocognitive Function Scores	Scores from the neurocognitive testing combined to give overall score for function.	Up to 1 day before delivery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf S Habib, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2014
• Primary Completion (Actual): April 13, 2022
• Study Completion (Actual): April 13, 2022

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging; Pre-Eclampsia; Neurocognitive Function
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Pregnancy Complications; Cognition Disorders; Hypertension, Pregnancy-Induced; Cognitive Dysfunction; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Pro00055293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No