protocolSection identificationModule nctId: NCT06388954, orgStudyIdInfo id: P.T.REC/012/005107, briefTitle: Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-05-09, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment., conditionsModule conditions: Stroke, conditions: Motor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-blind, randomized controlled study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA)., whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS), interventions name: Sham Trancutaneous auricular Vagus Nerve Stimulation, outcomesModule primaryOutcomes measure: Muscle tone of the upper limb, primaryOutcomes measure: Gross hand dexterity, primaryOutcomes measure: Level of Plasma brain-derived Derived factor (BDNF), primaryOutcomes measure: Level of Serum Interleukin IL-6, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, Cairo University, status: RECRUITING, city: Giza, state: Ad Doqi, Giza District, Giza Governorate, zip: 11432, country: Egypt, contacts name: Engy BadrEldin S Moustafa, PhD, role: CONTACT, phone: 00201099445112, email: engybm.saleh@cu.edu.eg, contacts name: Moshera H. Darwish, PhD, role: CONTACT, phone: 00201015163617, email: dr.moshera11@yahoo.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False