Nctid:
NCT06616831
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D000083302", "term"=>"Hemorrhagic Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M2404", "name"=>"Hemorrhagic Stroke", "asFound"=>"Stroke Hemorrhagic", "relevance"=>"HIGH"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Stroke, Ischemic", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>5}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-08-12", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Feasibility", "timeFrame"=>"2 weeks", "description"=>"We will assess dropout rates and compliance and subjective ratings of the device."}, {"measure"=>"Safety", "timeFrame"=>"2 weeks", "description"=>"We will assess any side effects or adverse events."}], "secondaryOutcomes"=>[{"measure"=>"Compliance", "timeFrame"=>"2 weeks", "description"=>"The total number of completed at-home sessions will be measured. The total stimulation duration completed within each session. Benchmarks of \\>80% total motor rehabilitation sessions completed, and 45 minute in-session duration will be the feasibility cutoffs for the analysis."}, {"measure"=>"Motor Function", "timeFrame"=>"2 weeks", "description"=>"Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA)."}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Stroke", "Stroke, Ischemic", "Stroke Hemorrhagic"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37209010", "type"=>"BACKGROUND", "citation"=>"Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20."}]}, "descriptionModule"=>{"briefSummary"=>"Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.", "detailedDescription"=>"This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve.\n\nThis project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits.\n\nInvestigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;\n* Ability to give consent;\n* Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;\n* active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;\n* Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.\n\nExclusion Criteria:\n\n* Other concomitant neurological disorders affecting upper extremity motor function;\n* Presence of Dysphagia or aspiration difficulties;\n* Prior injury to vagus nerve;\n* Pregnancy;\n* Documented history of dementia before or after stroke;\n* Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;\n* Uncontrolled hypertension;\n* Botox injections within 4 weeks of the first day of rehabilitation therapy."}, "identificationModule"=>{"nctId"=>"NCT06616831", "briefTitle"=>"At-Home TaVNS - Stroke Rehab", "organization"=>{"class"=>"OTHER", "fullName"=>"Medical University of South Carolina"}, "officialTitle"=>"Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation", "orgStudyIdInfo"=>{"id"=>"Pro00137256"}, "secondaryIdInfos"=>[{"id"=>"3P20GM109040-10W2", "link"=>"https://reporter.nih.gov/quickSearch/3P20GM109040-10W2", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training", "description"=>"Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.", "interventionNames"=>["Device: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training"]}], "interventions"=>[{"name"=>"Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training", "type"=>"DEVICE", "description"=>"Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.", "armGroupLabels"=>["Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"29403", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "contacts"=>[{"name"=>"Bashar Badran, PhD", "role"=>"CONTACT", "phone"=>"843-792-9502"}], "facility"=>"Medical University of South Carolina", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}], "centralContacts"=>[{"name"=>"Katie Tucker", "role"=>"CONTACT", "email"=>"tuckekat@musc.edu", "phone"=>"843-792-9502"}], "overallOfficials"=>[{"name"=>"Bashar Badran, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Medical University of South Carolina"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical University of South Carolina", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Bashar Badran", "investigatorAffiliation"=>"Medical University of South Carolina"}}}}
