Role of Hormones in Susceptibility to Seizures in Women With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00044252|
Recruitment Status : Completed
First Posted : August 23, 2002
Last Update Posted : July 2, 2017
This study will measure and compare hormone levels in women with catamenial epilepsy (epilepsy in which seizures are more frequent during menstrual periods), women with seizures not related to their menstrual cycle, and normal control subjects. It will determine whether there are differences among the three groups in their hormone levels or in how fast the levels change. It will also examine what relationship, if any, exists between hormone changes and seizures in women with catamenial epilepsy. The hormones under study include the gonadal hormones estrone, estradiol and progesterone, and the neuroactive steroids allopregnanolone, pregnenolone, and dehydroepiandrosterone.
Women who meet the following criteria may be eligible for this 3-month study:
- Between 18 and 45 years of age, with catamenial epilepsy
- Between 18 and 45 years of age, with seizures, but not catamenial epilepsy
- Between 18 and 45 years of age, without seizures
All participants will have a physical examination at the beginning of the study, at each clinic visit, and at completion or withdrawal from the study. In addition, they will undergo the following procedures:
For the first 2 months, all participants will keep a diary of their temperature and onset of menses. Women with epilepsy will also record their seizures.
Healthy volunteers will have a 45-minute EEG (recording of the electrical activity of the brain) at the beginning of each menstrual cycle and each day during the menses. Women with epilepsy will have continuous EEG monitoring for 8 days, beginning 5 days before their menstrual period is expected. The continuous monitoring can be done on an outpatient basis, using a portable EEG recording device, or as an inpatient, with admission to the hospital for the 8 days of recording.
All participants will have a small blood sample (2 teaspoons) drawn once a day on days 10, 14, 17, 19 and 21 of their menstrual cycle and three times a day on day 6 and for a period of 8 days, starting 5 days before the expected menses and continuing for 3 days of the next cycle. For the days with three blood draws, a small needle that can stay in place for up to 72 hours will be placed in the arm to avoid the discomfort of multiple needle sticks.
|Condition or disease|
Objectives. This is an initial pilot study to acquire information upon which a more specific, statistically rigorous follow-on investigation will be based. The objectives of the overall project are: (1) to compare the absolute levels and rates of change in levels of gonadal and neuroactive steroids in women with complex partial seizures and catamenial epilepsy with those of women with non-catamenial epilepsy and women volunteers without epilepsy, and (2) to determine if fluctuations in the levels of gonadal hormones (estrone, estradiol, progesterone) and neuroactive steroids (allopregnanolone, pregnenolone and dehydroepiandrosterone) correlate with seizure occurrence and the frequency of interictal spikes/wave discharges in women with catamenial seizure exacerbations.
Study Populations. Group A: adult women with complex partial seizures and catamenial exacerbations. Group B: adult women with complex partial seizures without catamenial seizure exacerbations. Group C: adult female volunteers without epilepsy.
Design. Subjects will undergo baseline monitoring of seizures and menses for two months prior to entry. Upon enrollment into the study, blood (10 ml) will be drawn for determinations of estradiol, estrone, progesterone, allopregnanolone, dehydroepiandrosterone (DHEA) and pregnenolone in all study populations once daily at 08:30 hr on menstrual cycle days, 10, 14, 17, 19 and 21; and three times daily at 08:30, 13:30 and 18:00 starting 5 days before expected menses and continuing for a total of 8 days as well as on menstrual cycle day 6. During 8 days starting 5 days before expected menses interictal spike activity and seizures will also be monitored continuously with EEG. Comparisons of the rates of change of hormone levels and spike and seizure frequency will be made using the time derivatives of fluctuations in hormone levels or hormone level ratios. Comparisons of time series data will be made using nonlinear regression with an arbitrary (cubic spine) model.
Outcome Parameters. The goal of this preliminary study is to obtain data regarding the fluctuation, during one menstrual cycle, of several hormones in epileptic and non-epileptic women of reproductive age. If the data show a relationship between (i) falling levels of plasma progesterone and allopregnanolone, (ii) increased levels of DHEA or pregnenolone or (iii) increased ratios of estrogen/progesterone, DHEA/progesterone, DHEA/allopregnanolone, pregnenolone/allopregnanolone and seizure manifestations and EEG documented interictal spike and seizure activity it would support the hypothesis that alterations in the levels of these steroid hormones are related to seizure exacerbations in women with catamenial epilepsy.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Role of Serum Gonadal and Neuroactive Steroids in the Seizure Susceptibility of Women With Catamenial Epilepsy|
|Study Start Date :||July 26, 2002|
|Estimated Study Completion Date :||January 22, 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044252
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|