Nctid:
NCT06228001
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D016472", "term"=>"Motor Neuron Disease"}, {"id"=>"D000690", "term"=>"Amyotrophic Lateral Sclerosis"}, {"id"=>"D012598", "term"=>"Sclerosis"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D013118", "term"=>"Spinal Cord Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D057177", "term"=>"TDP-43 Proteinopathies"}, {"id"=>"D057165", "term"=>"Proteostasis Deficiencies"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}], "browseLeaves"=>[{"id"=>"M15415", "name"=>"Sclerosis", "asFound"=>"Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M18879", "name"=>"Motor Neuron Disease", "asFound"=>"Lateral Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M4024", "name"=>"Amyotrophic Lateral Sclerosis", "asFound"=>"Amyotrophic Lateral Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M15915", "name"=>"Spinal Cord Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M28759", "name"=>"TDP-43 Proteinopathies", "relevance"=>"LOW"}, {"id"=>"M28747", "name"=>"Proteostasis Deficiencies", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"T349", "name"=>"Amyotrophic Lateral Sclerosis", "asFound"=>"Amyotrophic Lateral Sclerosis", "relevance"=>"HIGH"}, {"id"=>"T4699", "name"=>"Primary Lateral Sclerosis", "asFound"=>"Lateral Sclerosis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "targetDuration"=>"5 Years", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-05-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2028-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-24", "studyFirstSubmitDate"=>"2023-12-14", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point", "timeFrame"=>"1 year", "description"=>"95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second)."}, {"measure"=>"Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point", "timeFrame"=>"1 year", "description"=>"50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second)."}, {"measure"=>"Difference in 95th centile of stride length between baseline and one year follow up- or last time point", "timeFrame"=>"1 year", "description"=>"95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter)."}, {"measure"=>"Difference in 50th centile of stride length between baseline and one year follow up- or last time point", "timeFrame"=>"1 year", "description"=>"50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter)."}], "secondaryOutcomes"=>[{"measure"=>"Upper limb function evolution in patient with ALS", "timeFrame"=>"1 year", "description"=>"Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Actimyo", "Accelerometry", "Daily living"], "conditions"=>["Amyotrophic Lateral Sclerosis"]}, "descriptionModule"=>{"briefSummary"=>"ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS.\n\nThe investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.", "detailedDescription"=>"On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.\n\nParticipants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale).\n\nActimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients diagnosed with amyotrophic lateral sclerosis", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.\n* Over 18 years old.\n* Signed informed consent\n* If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.\n\nExclusion Criteria:\n\n* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.\n* Any other previous or present pathology having an impact on motor function.\n* Recent surgery or trauma (less than 6 months) in the upper or lower limbs.\n* Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.\n* Patients participating in an interventional clinical trial."}, "identificationModule"=>{"nctId"=>"NCT06228001", "acronym"=>"ActiALS", "briefTitle"=>"Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Universitaire de Liege"}, "officialTitle"=>"Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.", "orgStudyIdInfo"=>{"id"=>"ActiALS study"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Actimyo", "type"=>"DEVICE", "description"=>"Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"4000", "city"=>"Liège", "status"=>"RECRUITING", "country"=>"Belgium", "contacts"=>[{"name"=>"Stephanie Delstanche, MD", "role"=>"CONTACT", "email"=>"stephanie.delstanche@chrcitadelle.be"}, {"name"=>"Laura BUSCEMI", "role"=>"CONTACT", "email"=>"laura.buscemi@citadelle.be"}, {"name"=>"Stephanie Delstanche", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle", "geoPoint"=>{"lat"=>50.63373, "lon"=>5.56749}}], "centralContacts"=>[{"name"=>"Laura Buscemi", "role"=>"CONTACT", "email"=>"laura.buscemi@citadelle.be", "phone"=>"+3243215584"}, {"name"=>"Margaux Poleur, MD", "role"=>"CONTACT", "email"=>"margaux.poleur@citadelle.be", "phone"=>"+3243216127"}], "overallOfficials"=>[{"name"=>"Stéphanie Delstanche, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Laurent Servais", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"SYSNAV", "class"=>"INDUSTRY"}, {"name"=>"Centre Hospitalier Régional de la Citadelle", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Laurent Servais", "investigatorAffiliation"=>"Centre Hospitalier Universitaire de Liege"}}}}
