[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547092":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":45,"locations":53,"responsibleParty":70,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Sheffield Teaching Hospitals NHS Foundation Trust","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Vagus Nerve Stimulation","EXPERIMENTAL","The intervention will take place for up to 45 minutes per day, 5 days per week for 6 weeks. The stimulation device will be worn whilst completing computer-based Speech and Language Therapy.",[13,14],"Device: Transcutaneous Vagus Nerve Stimulation","Behavioral: Computer Based Speech and Language Therapy (Step by Step)",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham Transcutaneous Vagus Nerve Stimulation","SHAM_COMPARATOR","The sham intervention will take place for up to 45 minutes per day, 5 days per week for 6 weeks. The device will be in 'sham' mode. The stimulation device will be worn whilst completing computer-based Speech and Language Therapy.",[20,14],"Device: Sham Transcutaneous Vagus Nerve Stimulation",[22,27,30],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcutaneous auricular vagus nerve stimulation using the Nurosym (Parasym Ltd) device.\n\nStimulation parameters:\n\nPulse width: 250µs; Frequency: 25Hz; Intensity: Below pain threshold.\n\nThe active stimulation will be delivered to the left ear. Participants will complete the intervention at home once they have received sufficient training on how to use the stimulation device.",[9],null,{"type":23,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"Stimulation will be delivered at the same parameters however, sham stimulation will be delivered to the left ear. This sham method has been used as a sham in other studies as it is not thought to activate the vagus nerve.",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"BEHAVIORAL","Computer Based Speech and Language Therapy (Step by Step)","Computer-based Speech and Language Therapy will be completed whilst wearing the stimulation device in all groups. The Step by Step programme uses an errorless learning approach to practice naming. All participants will practice a set of 30 meaningful words during the intervention. Participants will complete the SLT programme at home on an ipad, whilst using the stimulation device.",[16,9],[36,39,43],{"name":37,"affiliation":5,"role":38},"Dr Ali Ali","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":42},"Prof. Arshad Majid","University of Sheffield","STUDY_DIRECTOR",{"name":44,"affiliation":41,"role":42},"Prof. Rebecca Palmer",[46,50],{"name":37,"role":47,"phone":48,"phoneExt":26,"email":49},"CONTACT","01142159114","ali.ali@sheffield.ac.uk",{"name":51,"role":47,"phone":26,"phoneExt":26,"email":52},"Miss Samantha Dorney","sldorney1@sheffield.ac.uk",[54],{"facility":5,"status":55,"city":56,"state":26,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Sheffield","S10 2JF","United Kingdom","UK",{"type":61,"coordinates":62},"Point",[63,64],-1.4659,53.38297,{"lat":64,"lon":63},[67,68],{"name":37,"role":47,"phone":48,"phoneExt":26,"email":49},{"name":51,"role":69,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100547092","transcutaneous-vagus-nerve-stimulation-in-aphasia-after-stroke-100547092",false,"NCT06403475","Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke","Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke: a Pilot Study","TRANSLATE","Inclusion Criteria:\n\n* Supratentorial stroke at least 6 months prior to recruitment\n* Aphasia (with word finding difficulties)\n* Ability to engage in the programme (support can be provided for cognitive or receptive difficulties)\n* Sufficient vision to engage in the computer-based SLT programme\n\nExclusion Criteria:\n\n* Implanted devices (e.g. pacemaker) or implanted stimulation devices\n* Currently receiving a programme of Speech and Language Therapy (SLT)\n* Damage to the vagus nerve\n* Symptomatic bradycardia\u002F 2nd or 3rd heart block\n* Pregnancy\n* Unable to speak English\n* Severe deafness (despite using hear aids)","ALL","18 Years",{"count":83,"type":84},36,"ESTIMATED","INTERVENTIONAL",[87],"NA","Aphasia is an acquired language disorder. Stroke is the most common cause of aphasia, which affects 30% of stroke survivors. Speech and Language Therapy (SLT) can help people with aphasia but it may not be provided at the required intensity. Access to therapy is often limited after the first few months following stroke. People with aphasia can improve with therapy many years after stroke but these benefits have not been found to translate to day to day conversation.\n\nTranscutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive technique which involves stimulating a branch of the vagus nerve through the skin of the ear, using a small earpiece. This technique is safe and has been approved for use in headache. There is promising evidence that tVNS can improve motor rehabilitation in chronic stroke. This technique may be helpful in aiding language recovery in individuals with chronic aphasia.\n\nThe current pilot study will primarily assess the feasibility, safety and tolerability of self-directed tVNS paired with computer-based SLT, in individuals with chronic stroke-related aphasia. Secondly, the study aims to explore the effect of the intervention on word-finding ability and to explore potential mechanisms of action. Participants will be randomly allocated to an active or sham tVNS group. Participants will be asked to use the stimulation device at home for 6 weeks, whilst completing computer-based SLT. To date, there are no published studies exploring the use of tVNS in aphasia. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.",[90,91],"Aphasia","Chronic Stroke",[93,94,95,96],"aphasia","vagus nerve stimulation","stroke","transcutaneous vagus nerve stimulation","2025-12-01",{"date":99,"type":100},"2025-12-08","ACTUAL",{"date":102,"type":100},"2024-04-25",{"date":104,"type":84},"2027-01-01",{"name":5,"class":6},1]