Nctid:
NCT00001666
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D004827", "term"=>"Epilepsy"}, {"id"=>"D012640", "term"=>"Seizures"}, {"id"=>"D004828", "term"=>"Epilepsies, Partial"}], "ancestors"=>[{"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M7983", "name"=>"Epilepsy", "asFound"=>"Epilepsy", "relevance"=>"HIGH"}, {"id"=>"M15452", "name"=>"Seizures", "asFound"=>"Seizures", "relevance"=>"HIGH"}, {"id"=>"M7984", "name"=>"Epilepsies, Partial", "asFound"=>"Partial Epilepsy", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008694", "term"=>"Methamphetamine"}], "ancestors"=>[{"id"=>"D000697", "term"=>"Central Nervous System Stimulants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D013566", "term"=>"Sympathomimetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D015259", "term"=>"Dopamine Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018663", "term"=>"Adrenergic Agents"}, {"id"=>"D018759", "term"=>"Adrenergic Uptake Inhibitors"}, {"id"=>"D014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D018765", "term"=>"Dopamine Uptake Inhibitors"}], "browseLeaves"=>[{"id"=>"M11674", "name"=>"Methamphetamine", "asFound"=>"Cup", "relevance"=>"HIGH"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}, {"id"=>"M16345", "name"=>"Sympathomimetics", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M20832", "name"=>"Dopamine Uptake Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>32}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-06", "completionDateStruct"=>{"date"=>"2002-06"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Seizures", "Partial Epilepsy", "Intractable", "TMS"], "conditions"=>["Partial Epilepsy", "Seizures"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3124709", "type"=>"BACKGROUND", "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."}, {"pmid"=>"7530636", "type"=>"BACKGROUND", "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."}, {"pmid"=>"8822690", "type"=>"BACKGROUND", "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."}]}, "descriptionModule"=>{"briefSummary"=>"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).\n\nEpilepsy 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.\n\nResearchers 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.", "detailedDescription"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Age 5 to 60 at entry to protocol.\n\nHistory of partial or Complex Partial Epilepsy for two or more years.\n\nPatients 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.\n\nSeizures 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.\n\nThe patients have a localized seizure focus.\n\nEpilepsy refractory to medical treatments.\n\nNo pregnant women (will be tested with urine pregnancy test).\n\nNo severe coronary disease.\n\nNo metal anywhere in the cranium except the mouth.\n\nNo intracardiac lines.\n\nNo increased intracranial pressure as expressed by the presence of papilledema.\n\nNo cardiac pacemakers.\n\nMust not be taking neuroleptic or antidepressant medications.\n\nNo progressive neurologic disease."}, "identificationModule"=>{"nctId"=>"NCT00001666", "briefTitle"=>"Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Drug Refractory Partial Epilepsy, A Therapeutic Trial With Transcranial Magnetic Stimulation", "orgStudyIdInfo"=>{"id"=>"970092"}, "secondaryIdInfos"=>[{"id"=>"97-N-0092"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cadwell High-Speed Magnetoelectric Stimulator", "type"=>"DEVICE"}, {"name"=>"Magpro High-Speed Magnetoelectric Stimulator", "type"=>"DEVICE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "class"=>"NIH"}}}}
