Nctid:
NCT00001663
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D009069", "term"=>"Movement Disorders"}, {"id"=>"D009207", "term"=>"Myoclonus"}], "ancestors"=>[{"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D020820", "term"=>"Dyskinesias"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M12029", "name"=>"Movement Disorders", "asFound"=>"Movement Disorders", "relevance"=>"HIGH"}, {"id"=>"M12159", "name"=>"Myoclonus", "asFound"=>"Myoclonus", "relevance"=>"HIGH"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M22574", "name"=>"Dyskinesias", "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"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>10}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-01", "completionDateStruct"=>{"date"=>"2002-01"}, "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"=>["Neurological Disorders", "Movement Disorders", "Physiology", "Noninvasive", "Brain Stimulation", "Cortical Myoclonus"], "conditions"=>["Movement Disorder", "Myoclonus", "Nervous System Disease"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1407578", "type"=>"BACKGROUND", "citation"=>"Cantello R, Gianelli M, Civardi C, Mutani R. Magnetic brain stimulation: the silent period after the motor evoked potential. Neurology. 1992 Oct;42(10):1951-9. doi: 10.1212/wnl.42.10.1951."}, {"pmid"=>"8410704", "type"=>"BACKGROUND", "citation"=>"Inghilleri M, Berardelli A, Cruccu G, Manfredi M. Silent period evoked by transcranial stimulation of the human cortex and cervicomedullary junction. J Physiol. 1993 Jul;466:521-34."}, {"pmid"=>"1714819", "type"=>"BACKGROUND", "citation"=>"Fuhr P, Agostino R, Hallett M. Spinal motor neuron excitability during the silent period after cortical stimulation. Electroencephalogr Clin Neurophysiol. 1991 Aug;81(4):257-62. doi: 10.1016/0168-5597(91)90011-l."}]}, "descriptionModule"=>{"briefSummary"=>"Myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the limbs.\n\nThe purpose of this study is to determine if stimulation of the brain with magnetic pulses can decrease myoclonus. Researchers believe that this may be possible because in studies on normal volunteers, magnetic stimulation made areas of the brain difficult to activate for several minutes. In addition, early studies on patients with myoclonus have shown magnetic stimulation to be effective at decreasing involuntary movements.\n\nTranscranial 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 and spinal cord related to motor activity (motor cortex and corticospinal tract). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and off the electrical current. The changing magnetic field produces weak electrical currents in the brain near the coil. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.\n\nResearchers plan to use rTMS for 10 days on patients participating in the study. The 10 day period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of placebo \"ineffective\" stimulation. At the end of the 10 day period, if the results show that rTMS was beneficial, patients may undergo an additional 5 days of active rTMS.", "detailedDescription"=>"Repetitive transcranial magnetic stimulation (rTMS) at frequencies in the single Hz range causes a decrease in the excitability of the primary motor cortex and there is preliminary evidence that it can suppress abnormal excess cortical activity. We plan to test 1 Hz rTMS as treatment for cortical myoclonus."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Age 5 to 90 with severe cortical myoclonus.\n\nNo intracranial metal hardware (excluding dental fillings), pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or increased intracranial pressure.\n\nSubject must not be pregnant."}, "identificationModule"=>{"nctId"=>"NCT00001663", "briefTitle"=>"Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation", "orgStudyIdInfo"=>{"id"=>"970053"}, "secondaryIdInfos"=>[{"id"=>"97-N-0053"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Magstim Super Rapid 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"}}}}
