Nctid:
NCT00001208
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009069", "term"=>"Movement Disorders"}], "ancestors"=>[{"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M12029", "name"=>"Movement Disorders", "asFound"=>"Movement Disorders", "relevance"=>"HIGH"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5183", "name"=>"Botulinum Toxins", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>2000}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"1989-10-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11-19", "lastUpdateSubmitDate"=>"2024-11-20", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-21", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Study Natural History- data analysis", "timeFrame"=>"Ongoing", "description"=>"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."}, {"measure"=>"Maintain cohort of subjects", "timeFrame"=>"Ongoing", "description"=>"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"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Botulinum Toxin", "BTW", "Natural History"], "conditions"=>["Movement Disorders"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1985-N-0195.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response.\n\nThe application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.", "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 NIH studies."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"2 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with a movement disorder will be enrolled.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\n 1. Patients 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.\n 2. Applicable 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\n1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.\n2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.\n3. For 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"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Botulinum Toxin for the Treatment of Neurological Disorders", "orgStudyIdInfo"=>{"id"=>"850195"}, "secondaryIdInfos"=>[{"id"=>"85-N-0195"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients", "description"=>"Patients 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. Applicable 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."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "role"=>"CONTACT", "email"=>"ccopr@nih.gov", "phone"=>"800-411-1222", "phoneExt"=>"TTY dial 711"}], "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "centralContacts"=>[{"name"=>"Vivian S Koo", "role"=>"CONTACT", "email"=>"vivian.koo@nih.gov", "phone"=>"(301) 435-8518"}, {"name"=>"Debra J Ehrlich, M.D.", "role"=>"CONTACT", "email"=>"debra.ehrlich@nih.gov", "phone"=>"(301) 443-7888"}], "overallOfficials"=>[{"name"=>"Debra J Ehrlich, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Neurological Disorders and Stroke (NINDS)"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"Data will be shared indefinitely.", "ipdSharing"=>"YES", "description"=>"All collected IPD stored in the database will be shared. @@@@@@@@@@@@We may share identifiable research data with other NIH protocols, when subjects are co-enrolled. Data can be shared with other protocols, investigators, and subject health care and medical team upon subject requests and permissions. Data that may be shared are demographics, diagnosis, botulinum toxin injections (including site, dose, localication technique), response to injections, assessments from clinical evaluations and clinical rating scales or test results that are conducted for each subject. Data that is shared may be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH. @@@@@@@@@@@@", "accessCriteria"=>"We do plan on broad data sharing. Therefore, there will be no restrictions on whom the data can be shared with."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
