NCT00054990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2004

First QC Date

February 15, 2003

Last Update Submit

March 3, 2008

Conditions

Healthy

Keywords

Antiepileptic DrugsCortical ExcitabilityTranscranial Magnetic StimulationEpilepsyTMSHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients will be excluded from this study if they:
  • are pregnant (tested with urine pregnancy test).
  • have severe coronary disease.
  • have metal anywhere in the cranium except the mouth.
  • have intracardiac lines.
  • have increased intracranial pressure as expressed by the presence of papilledema.
  • have cardiac pacemakers.
  • take neuroleptic or antidepressant medications.
  • any neurologic disease including epilepsy.
  • taking any psychiatric drugs.
  • any other documented systemic illness.
  • history of drug allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Burstein AH, Horton RL, Dunn T, Alfaro RM, Piscitelli SC, Theodore W. Lack of effect of St John's Wort on carbamazepine pharmacokinetics in healthy volunteers. Clin Pharmacol Ther. 2000 Dec;68(6):605-12. doi: 10.1067/mcp.2000.111530.

    PMID: 11180020BACKGROUND

  • Cantello R, Civardi C, Cavalli A, Varrasi C, Tarletti R, Monaco F, Migliaretti G. Cortical excitability in cryptogenic localization-related epilepsy: interictal transcranial magnetic stimulation studies. Epilepsia. 2000 Jun;41(6):694-704. doi: 10.1111/j.1528-1157.2000.tb00230.x.

    PMID: 10840401BACKGROUND

  • Chen R, Samii A, Canos M, Wassermann EM, Hallett M. Effects of phenytoin on cortical excitability in humans. Neurology. 1997 Sep;49(3):881-3. doi: 10.1212/wnl.49.3.881.

    PMID: 9305361BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 15, 2003

First Posted

February 17, 2003

Study Start

February 1, 2003

Study Completion

March 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-03

Locations

US(1)