Nctid:
NCT06231810
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2028-07-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-22", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-07-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Peripheral nerve function", "timeFrame"=>"30 minutes during the first session of a one session evaluation protocol", "description"=>"Electrotactile stimuli will be applied to a finger, with the current (A) changing in magnitude. We will measure the level to which the peripheral nerve is activated using surface electrodes, which identify changes in voltage along the nerve."}], "primaryOutcomes"=>[{"measure"=>"Conscious detection threshold", "timeFrame"=>"30 minutes during the first session of a one session protocol", "description"=>"The magnitude at which a force stimulus applied to the finger can be first consciously detected. Different force levels will be applied, and the participant will indicate which of these forces can be detected. The changes in force applied will be in the units of N."}], "secondaryOutcomes"=>[{"measure"=>"Brain activation", "timeFrame"=>"60 minutes during the first session of a one session protocol", "description"=>"The magnitude and regions of brain activated in response to differing levels of force stimuli will be captured using fMRI. The % signal change in the brain will be used to define the brain activation in response to each force stimulus level."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Stroke", "Tactile Perception"]}, "descriptionModule"=>{"briefSummary"=>"Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n-right-hand dominance for participants who are neurotypical\n\nFor Aim 1:\n\n-age range of 18-23\n\nFor Aim 2:\n\n* participants who are neurotypical will be a similar age to the participants with stroke\n* participants who are neurotypical will have no musculoskeletal and neurological conditions\n* participants with stroke will have a single stroke incident resulting in a unilateral lesion (ischemic and hemorrhagic)\n* participants with stroke will be in the chronic phase (\\>1 year from stroke onset)\n* participants with stroke will have an onset of stroke after the age of 18\n* participants with stroke who meet the criteria of having the capacity to provide informed consent, regardless of aphasia\n\nExclusion Criteria:\n\n* minors\n* pregnant women\n* prisoners\n* adults not capable of consenting on their own behalf.\n\nFor Aim 2:\n\n* participants with stroke who have used antispastic injections in the past six months\n* participants with stroke who have a lesion in the brainstem and/or cerebellum\n* participants with stroke who have a stroke arising due to brain surgery\n* participants with stroke who have hemineglect"}, "identificationModule"=>{"nctId"=>"NCT06231810", "briefTitle"=>"Tracking a Tactile Signal Along the Nervous System", "organization"=>{"class"=>"OTHER", "fullName"=>"Virginia Polytechnic Institute and State University"}, "officialTitle"=>"Tracking a Tactile Signal Along the Nervous System", "orgStudyIdInfo"=>{"id"=>"23-1256"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Stimulus magnitude", "description"=>"Differing levels of tactile stimulus will be applied", "interventionNames"=>["Behavioral: Tactile stimulation"]}], "interventions"=>[{"name"=>"Tactile stimulation", "type"=>"BEHAVIORAL", "description"=>"Tactile stimuli of differing magnitudes will be applied", "armGroupLabels"=>["Stimulus magnitude"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"24016", "city"=>"Roanoke", "state"=>"Virginia", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Anna Feldbush", "role"=>"CONTACT", "email"=>"touchperception231256@vt.edu", "phone"=>"540-231-7482"}], "facility"=>"Virginia Tech", "geoPoint"=>{"lat"=>37.27097, "lon"=>-79.94143}}], "centralContacts"=>[{"name"=>"Netta Gurari, PhD", "role"=>"CONTACT", "email"=>"gurari@vt.edu", "phone"=>"540-231-3073"}], "overallOfficials"=>[{"name"=>"Netta Gurari, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Virginia Polytechnic Institute and State University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Virginia Polytechnic Institute and State University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Netta Gurari", "investigatorAffiliation"=>"Virginia Polytechnic Institute and State University"}}}}
