The Effects of the Female Hormones on Cerebral Perfusion

NCT03299179 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2023-12-06

No results posted yet for this study

Summary

Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain activity, brain connectivity and white matter diffusion) caused by the female sex hormones and hormonal contraception.

Conditions

  • Cerebral Perfusion
  • Contraception
  • Menstrual Cycle

Interventions

DEVICE

MRI scan

Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).

DEVICE

Physiological monitoring

During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance

BIOLOGICAL

Blood sample

Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.

DEVICE

Blood pressure measurement

Measuring blood pressure before and after MRI-scan

DEVICE

Body temperature

Measuring body temperature before and after MRI-scan

OTHER

Questionnaires

Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)

DIAGNOSTIC_TEST

Pregnancy test

Test for pregnancy using a pregnancy dipstick test

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Eric Achten, MD, PhD · University Hospital, Ghent

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-03
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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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 NCT03299179 on ClinicalTrials.gov