Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Partial Epilepsy Seizures |
Device: Cadwell High-Speed Magnetoelectric Stimulator Device: Magpro High-Speed Magnetoelectric Stimulator |
| Study Type: | Observational |
| Official Title: | Drug Refractory Partial Epilepsy, A Therapeutic Trial With Transcranial Magnetic Stimulation |
| Estimated Enrollment: | 32 |
| Study Start Date: | March 1997 |
| Estimated Study Completion Date: | June 2002 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00001666 History of Changes |
| Other Study ID Numbers: | 970092, 97-N-0092 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Seizures Partial Epilepsy Intractable TMS |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Seizures Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013