Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	March 1997
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy
Official Title ^ICMJE	Drug Refractory Partial Epilepsy, A Therapeutic Trial With Transcranial Magnetic Stimulation
Brief Summary	Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum). Epilepsy is a condition associated with seizures as a result of an over excitable cerebral cortex. Despite the introduction of several new antiepileptic medications, less than half of the patients diagnosed with partial epilepsy are well controlled. However, studies have shown that non-invasive stimulation of the brain can decrease the excitability of the cerebral cortex. Researchers are interested in the potential therapeutic effects of TMS on patients with epilepsy that have responded poorly to standard medication. This study will use TMS to decrease the excitability of the areas of the brain responsible for seizures.
Detailed Description	The purpose of this protocol is to study the effects of transcranial magnetic stimulation (TMS) at 1 Hz on the excitability of the seizure focus in patients with poorly controlled epilepsy refractory to pharmacological treatments. 1 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Partial Epilepsy Seizures
Intervention ^ICMJE	Device: Cadwell High-Speed Magnetoelectric Stimulator Device: Magpro High-Speed Magnetoelectric Stimulator
Study Arms / Comparison Groups
Publications *	Abou-Khalil BW, Siegel GJ, Sackellares JC, Gilman S, Hichwa R, Marshall R. Positron emission tomography studies of cerebral glucose metabolism in chronic partial epilepsy. Ann Neurol. 1987 Oct;22(4):480-6. Classen J, Witte OW, Schlaug G, Seitz RJ, Holthausen H, Benecke R. Epileptic seizures triggered directly by focal transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1995 Jan;94(1):19-25. Derby LE, Tennis P, Jick H. Sudden unexplained death among subjects with refractory epilepsy. Epilepsia. 1996 Oct;37(10):931-5.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	June 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Age 5 to 60 at entry to protocol. History of partial or Complex Partial Epilepsy for two or more years. Patients should be on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. Blood levels of anti-convulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant. Seizures not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have failed at least two anti-convulsant regimens in the past. The patients have a localized seizure focus. Epilepsy refractory to medical treatments. No pregnant women (will be tested with urine pregnancy test). No severe coronary disease. No metal anywhere in the cranium except the mouth. No intracardiac lines. No increased intracranial pressure as expressed by the presence of papilledema. No cardiac pacemakers. Must not be taking neuroleptic or antidepressant medications. No progressive neurologic disease.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001666
Responsible Party
Study ID Numbers ^ICMJE	970092, 97-N-0092
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	June 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP