Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054990
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-02-15
Brief Title:
Effects of Antiepileptic Drugs on Brain Excitability
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects Of Antiepileptic Drugs On Cortical Excitability
Status:
COMPLETED
Status Verified Date:
2004-03
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 evaluate the usefulness of transcranial magnetic stimulation TMS in measuring cortical excitability The cortex is the outer part of the brain Patients with seizures have increased cortical excitability and are often treated with antiepileptic drugs to reduce this excitability The therapeutic effects of antiepileptic drugs are usually tracked with blood tests that measure their blood levels However these blood tests may not always correctly reflect the effects of the drugs on the brain
TMS has been used successfully to measure cortical excitability in many neurological diseases including epilepsy and may be helpful in measuring drug effects on the brain directly For this procedure a wire coil is held over the scalp A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain This may cause a pulling sensation on the skin under the coil and twitching in muscles of the face arm or leg During the stimulation the participant may be asked to tense certain muscles slightly or perform other simple actions
Healthy normal volunteers between 18 and 55 years of age may be eligible for this study Candidates will be screened with a medical history physical and neurological examination electroencephalogram EEG and blood tests
On the first day of the study participants will have a baseline TMS and will be randomly assigned to take one of two antiepileptic drugs group A will take the carbamazepine group B will take lamotrigine If they wish participants may be admitted to the NIH Clinical Center for the first 5 days of drug administration while the proper dosage is being determined They will then be discharged and continue taking the drug for a total of 36 days During this time they will have daily blood tests and TMS from days 2 through 5 and again on days 12 and 36 Group A will have additional blood sampling and TMS on days 37 39 44 and 53 Group B will have blood tests and TMS on days 38 40 45 and 53
TMS has been used successfully to measure cortical excitability in many neurological diseases including epilepsy and may be helpful in measuring drug effects on the brain directly For this procedure a wire coil is held over the scalp A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain This may cause a pulling sensation on the skin under the coil and twitching in muscles of the face arm or leg During the stimulation the participant may be asked to tense certain muscles slightly or perform other simple actions
Healthy normal volunteers between 18 and 55 years of age may be eligible for this study Candidates will be screened with a medical history physical and neurological examination electroencephalogram EEG and blood tests
On the first day of the study participants will have a baseline TMS and will be randomly assigned to take one of two antiepileptic drugs group A will take the carbamazepine group B will take lamotrigine If they wish participants may be admitted to the NIH Clinical Center for the first 5 days of drug administration while the proper dosage is being determined They will then be discharged and continue taking the drug for a total of 36 days During this time they will have daily blood tests and TMS from days 2 through 5 and again on days 12 and 36 Group A will have additional blood sampling and TMS on days 37 39 44 and 53 Group B will have blood tests and TMS on days 38 40 45 and 53
Detailed Description:
Objectives Epilepsy is a condition characterized by abnormally increased cortical excitability and antiepileptic drugs AEDs control epilepsy by reducing cortical excitability Serum blood levels presently represent the standard measure utilized to track the therapeutic effects of AEDs However peripheral blood levels do not always reflect brain levels or provide direct information on cortical excitability Transcranial magnetic stimulation TMS is a non-invasive technique that allows accurate measures of this parameter The purpose of this protocol is to test the hypothesis that TMS measures of cortical excitability will correlate with serum blood levels of AEDs and reflect clinical effects on cortical function directly in healthy volunteers This information is crucial to reach the ultimate goal of developing a reliable quantitative measurement of central physiological effects of AEDs in epileptic patients
Study Population 40 normal volunteers aged 18 to 55 years will be recruited for this study
Design Subjects will be assigned to either of two groups with each group receiving one of the following drugs carbamazepine CBZ and lamotrigine LTG Measures of cortical excitability will be performed using TMS in various drug treatment phases at baseline before drug intake during the AED induction period once a day for the first 5 days after 12 days of drug intake at the maximum dose during steady state and 3 7 and 14 half-lives after and finally three weeks after abrupt drug withdrawal Blood sampling for drug levels will be performed at each TMS study
Outcome Measures The primary outcome variables will be MEP size measured from recruitment curves MEP size difference from baseline will be compared to the serum drug level for each drug
Study Population 40 normal volunteers aged 18 to 55 years will be recruited for this study
Design Subjects will be assigned to either of two groups with each group receiving one of the following drugs carbamazepine CBZ and lamotrigine LTG Measures of cortical excitability will be performed using TMS in various drug treatment phases at baseline before drug intake during the AED induction period once a day for the first 5 days after 12 days of drug intake at the maximum dose during steady state and 3 7 and 14 half-lives after and finally three weeks after abrupt drug withdrawal Blood sampling for drug levels will be performed at each TMS study
Outcome Measures The primary outcome variables will be MEP size measured from recruitment curves MEP size difference from baseline will be compared to the serum drug level for each drug
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 |
|---|---|---|---|
| 03-N-0107 | None | None | None |