Nctid:
NCT00001208
Payload:
{"FullStudy"=>{"Rank"=>474422, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009069", "ConditionMeshTerm"=>"Movement Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11719", "ConditionBrowseLeafName"=>"Movement Disorders", "ConditionBrowseLeafAsFound"=>"Movement Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M4873", "InterventionBrowseLeafName"=>"Botulinum Toxins", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"2000"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"October 26, 1989", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 1, 2023", "LastUpdateSubmitDate"=>"December 7, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 8, 2023", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Study Natural History- data analysis", "PrimaryOutcomeTimeFrame"=>"Ongoing", "PrimaryOutcomeDescription"=>"Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment."}, {"PrimaryOutcomeMeasure"=>"Maintain cohort of subjects", "PrimaryOutcomeTimeFrame"=>"Ongoing", "PrimaryOutcomeDescription"=>"To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection"}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Botulinum Toxin", "BTW", "Natural History"]}, "ConditionList"=>{"Condition"=>["Movement Disorders"]}}, "ReferencesModule"=>{"SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1985-N-0195.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such as stuttering and problems with the muscles of the eyes.\n\nThe study examines the effectiveness of botulinum toxin as treatment for a variety of movement disorders. The goals of the study are to refine the technique of treatment to provide the best results, to improve the understanding of how botulinum toxin works on movement disorders, and find other conditions that may be treatable with botulinum toxin.\n\nIn addition, researchers also plan to study the possible use of botulinum toxin F alone and in combination with botulinum toxin A in patients who do not respond to botulinum A toxin treatment.<TAB>", "DetailedDescription"=>"The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other studies on the physiology of sensorimotor systems and on the physiological effects of botulinum toxin."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"2 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "SamplingMethod"=>"Probability Sample", "StudyPopulation"=>"Primary clinical- Patients are evaluated for treatment with BTX in the movement disorders clinic of the Human Motor Control Section or by the Voice and Speech section, NINDS.", "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPatients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.\nApplicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.\n\nEXCLUSION CRITERIA:\n\nWomen who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.\nSubjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.\nFor laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders."}, "IdentificationModule"=>{"NCTId"=>"NCT00001208", "BriefTitle"=>"Botulinum Toxin for the Treatment of Involuntary Movement Disorders", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Botulinum Toxin for the Treatment of Neurological Disorders", "OrgStudyIdInfo"=>{"OrgStudyId"=>"850195"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"85-N-0195"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"Patients", "ArmGroupDescription"=>"Patients will be eligible for participation if they have a movement disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX."}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center", "LocationContactList"=>{"LocationContact"=>[{"LocationContactName"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "LocationContactRole"=>"Contact", "LocationContactEMail"=>"ccopr@nih.gov", "LocationContactPhone"=>"800-411-1222", "LocationContactPhoneExt"=>"TTY dial 711"}]}}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"Vivian S Koo", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"vivian.koo@nih.gov", "CentralContactPhone"=>"(301) 435-8518"}, {"CentralContactName"=>"Debra J Ehrlich, M.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"debra.ehrlich@nih.gov", "CentralContactPhone"=>"(301) 443-7888"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Debra J Ehrlich, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Neurological Disorders and Stroke (NINDS)"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"Undecided", "IPDSharingDescription"=>".Since this protocol is primarily a screening protocol, it may not be feasible to make data available on an individual patient level."}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
