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Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy

Primary Purpose

Partial Epilepsy, Seizures

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Cadwell High-Speed Magnetoelectric Stimulator
Magpro High-Speed Magnetoelectric Stimulator
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Partial Epilepsy focused on measuring Seizures, Partial Epilepsy, Intractable, TMS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001666
Brief Title
Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy
Official Title
Drug Refractory Partial Epilepsy, A Therapeutic Trial With Transcranial Magnetic Stimulation
Study Type
Observational

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy, Seizures
Keywords
Seizures, Partial Epilepsy, Intractable, TMS

7. Study Design

Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cadwell High-Speed Magnetoelectric Stimulator
Intervention Type
Device
Intervention Name(s)
Magpro High-Speed Magnetoelectric Stimulator

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3124709
Citation
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.
Results Reference
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PubMed Identifier
7530636
Citation
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.
Results Reference
background
PubMed Identifier
8822690
Citation
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.
Results Reference
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Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy

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