Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy
NCT ID: NCT00001666
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
1997-03-31
2002-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Interventions
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Cadwell High-Speed Magnetoelectric Stimulator
Magpro High-Speed Magnetoelectric Stimulator
Eligibility Criteria
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Inclusion Criteria
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.
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
Countries
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References
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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. doi: 10.1002/ana.410220407.
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. doi: 10.1016/0013-4694(94)00249-k.
Derby LE, Tennis P, Jick H. Sudden unexplained death among subjects with refractory epilepsy. Epilepsia. 1996 Oct;37(10):931-5. doi: 10.1111/j.1528-1157.1996.tb00529.x.
Other Identifiers
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97-N-0092
Identifier Type: -
Identifier Source: secondary_id
970092
Identifier Type: -
Identifier Source: org_study_id
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