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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03863639
• Other study ID #: Pro00055293
• Status: Terminated
• Start date: July 7, 2014
• Est. completion date: April 13, 2022

Study information

• Verified date: June 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Eclampsia
• Neurocognitive Dysfunction
• Pre-Eclampsia

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

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