Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044252
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-08-22
Brief Title:
Role of Hormones in Susceptibility to Seizures in Women With Epilepsy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of Serum Gonadal and Neuroactive Steroids in the Seizure Susceptibility of Women With Catamenial Epilepsy
Status:
COMPLETED
Status Verified Date:
2008-01-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Baseline Monitoring
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
Electroencephalography EEG
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
Blood Sampling
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
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
Baseline Monitoring
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
Electroencephalography EEG
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
Blood Sampling
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
Detailed Description:
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 spikeswave 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 0830 hr on menstrual cycle days 10 14 17 19 and 21 and three times daily at 0830 1330 and 1800 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 estrogenprogesterone DHEAprogesterone DHEAallopregnanolone pregnenoloneallopregnanolone 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 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 0830 hr on menstrual cycle days 10 14 17 19 and 21 and three times daily at 0830 1330 and 1800 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 estrogenprogesterone DHEAprogesterone DHEAallopregnanolone pregnenoloneallopregnanolone 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0256 | None | None | None |