Tracking a Tactile Signal Along the Nervous System
Launched by VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY · Jan 26, 2024

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Nctid: NCT06231810

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "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"}}}}

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Trial Information

Current as of December 30, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "Tracking a Tactile Signal Along the Nervous System," is studying how touch signals travel from our fingers through the nervous system to the brain. It aims to understand the journey of these signals in two groups: young adults without any health issues and individuals who have had a stroke. By examining how these touch signals are processed, researchers hope to learn more about tactile perception, which is our ability to feel and interpret touch.

To be eligible for the trial, participants should be right-handed and fall within specific age groups. For the first part of the study, young adults aged 18 to 23 can participate. For the second part, individuals who have had a stroke and those who are neurotypical (without neurological conditions) will be matched in age. Participants can expect to engage in activities that measure how they perceive touch. It's important to note that certain individuals, such as minors, pregnant women, and those with specific medical histories, will not be able to participate. Overall, this trial could provide valuable insights into how our nervous system processes touch, especially for those who have experienced a stroke.

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• -right-hand dominance for participants who are neurotypical
For Aim 1:
• -age range of 18-23
For Aim 2:
• participants who are neurotypical will be a similar age to the participants with stroke
• participants who are neurotypical will have no musculoskeletal and neurological conditions
• participants with stroke will have a single stroke incident resulting in a unilateral lesion (ischemic and hemorrhagic)
• participants with stroke will be in the chronic phase (\>1 year from stroke onset)
• participants with stroke will have an onset of stroke after the age of 18
• participants with stroke who meet the criteria of having the capacity to provide informed consent, regardless of aphasia
Exclusion Criteria:
• minors
• pregnant women
• prisoners
• adults not capable of consenting on their own behalf.
For Aim 2:
• participants with stroke who have used antispastic injections in the past six months
• participants with stroke who have a lesion in the brainstem and/or cerebellum
• participants with stroke who have a stroke arising due to brain surgery
• participants with stroke who have hemineglect

Trial Officials

Netta Gurari, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

About Virginia Polytechnic Institute And State University

Virginia Polytechnic Institute and State University, commonly known as Virginia Tech, is a leading public research university renowned for its commitment to innovation and excellence in education. With a strong emphasis on interdisciplinary collaboration, Virginia Tech fosters advancements in various fields, including health sciences and engineering. The university actively engages in clinical research to address pressing health challenges, leveraging its state-of-the-art facilities and expert faculty to conduct rigorous clinical trials. Through its initiatives, Virginia Tech aims to enhance patient care and contribute to the scientific community's understanding of diverse health issues.

Locations

Roanoke, Virginia, United States

People applied

0 patients applied

Timeline

First submit

January 08, 2024

Trial launched

February 29, 2024

Trial updated

March 22, 2024

Estimated completion

Not reported

Discussion 0

Tracking a Tactile Signal Along the Nervous System Launched by VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY · Jan 26, 2024

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Tracking a Tactile Signal Along the Nervous System
Launched by VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY · Jan 26, 2024