[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719387":3,"trial-entities:NCT07719387":120,"trial-summary:NCT07719387":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":44,"secondary_outcomes":52,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":103,"locations":106,"central_contacts":116,"overall_officials":117,"references":118,"see_also_links":119},"NCT07719387","IRB2025-00209","Vagal Nerve Stimulation To Enhance Cognition and Learning","Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients","ENROLLING_BY_INVITATION","2026-12","2026-01","2026-07-22","2025-11-17","Stony Brook University","OTHER",true,"The purpose of this study is to find out whether pairing vagus nerve stimulation (VNS) with cognitive training can improve memory and language learning in people who have previously used VNS therapy for movement rehabilitation after a stroke. VNS has been previously used to support motor recovery after stroke, but its effect on cognitive learning is not yet fully understood. This study is enrolling individuals who already have a VNS device implanted and have successfully completed VNS-assisted movement therapy. The investigators aim to explore whether continuing to use the device during a language learning program may also support memory and cognitive improvement. This is a research study, which means the use of VNS for cognitive enhancement is experimental and not currently part of standard treatment. An exploratory MRI\u002FfMRI component also will assess whether VNS-paired language learning is associated with changes in task-based activation and resting-state functional connectivity in language, memory, salience\u002Farousal, and frontoparietal cognitive-control networks. The information learned may help guide future approaches to stroke rehabilitation and cognitive recovery.","Stroke survivors frequently experience persistent cognitive, memory, and language-related difficulties that can affect independence and quality of life. VNS paired with rehabilitation has been shown to enhance motor recovery after stroke, and paired stimulation may support experience-dependent neural plasticity. This study extends that approach to cognitive and language learning by pairing VNS with structured foreign-language vocabulary training.\n\nEligible participants will be adults with prior stroke who are scheduled to receive, or have received, clinically indicated Vivistim VNS implantation for rehabilitation and who are able to participate in the language-learning intervention. Participants will be randomized to active VNS or sham stimulation during daily language-learning sessions over approximately six weeks. The active stimulation group will receive programmed VNS paired with language-learning stimuli; the sham group will undergo the same language-learning procedures with stimulation amplitude set to zero or otherwise configured according to the sham protocol. Participants will be blinded to group assignment when feasible.\n\nThe neuroimaging sub-study will include MRI\u002FfMRI at up to three time points: pre-surgery baseline, when feasible before clinically indicated implantation; post-surgery\u002Fpre-language-training baseline; and post-training. The post-surgery\u002Fpre-training scan is the key baseline for the language-learning intervention, particularly for participants who already have the device implanted. MRI sessions will include structural MRI, resting-state fMRI, and a task-based foreign-word semantic matching paradigm. The primary task-based fMRI contrast will examine changes in neural responses to future-trained versus trained foreign words compared with never-trained foreign words. Resting-state analyses will examine changes in functional connectivity across language, memory, salience\u002Farousal, frontoparietal cognitive control, and stroke recovery networks. A brief optional 0-back\u002F1-back working-memory fMRI task may be included if scan time and participant tolerance allow.",[19,20,21,22],"Vagus Nerve Stimulation","Stroke","Cognitive Assessment","Language Acquisition",[24,25,26,27,28],"VNS","VNS for learning and cognition","stroke rehabilitation","fMRI","neuromodulation","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},20,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","VNS for Cognition","Subjects previously implanted with VNS will undergo second language acquisition",[42,43],"Sham Group","VNS Group",[45,49],{"measure":46,"description":47,"timeFrame":48},"Change in Foreign-Language Vocabulary Learning Accuracy","Vocabulary learning will be assessed using trained foreign-language vocabulary items. The outcome is the percentage of trained vocabulary items correctly recalled, recognized, or translated. Scores range from 0% to 100%, with higher scores indicating better vocabulary learning.","Baseline and 6 weeks",{"measure":50,"description":51,"timeFrame":48},"Change in Foreign-Language Sentence Learning Accuracy","Sentence learning will be assessed using trained short foreign-language sentences. The outcome is the percentage of trained sentence items correctly understood, completed, recalled, or translated. Scores range from 0% to 100%, with higher scores indicating better sentence learning.",[53,57,60,63,66,69,72,75],{"measure":54,"description":55,"timeFrame":56},"Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)","Global cognition will be measured using the Montreal Cognitive Assessment total score. Scores range from 0 to 30, with higher scores indicating better cognitive function.","6 weeks",{"measure":58,"description":59,"timeFrame":56},"Change in Verbal Learning on the Rey Auditory Verbal Learning Test","Verbal learning will be measured as the total number of words recalled across Rey Auditory Verbal Learning Test learning trials. Scores range from 0 to 75, with higher scores indicating better verbal learning.",{"measure":61,"description":62,"timeFrame":56},"Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test","Delayed verbal memory will be measured as the number of words recalled after a delay on the Rey Auditory Verbal Learning Test. Scores range from 0 to 15, with higher scores indicating better delayed verbal memory.",{"measure":64,"description":65,"timeFrame":56},"Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised","Verbal learning will be measured as the total number of words recalled across Hopkins Verbal Learning Test-Revised immediate recall trials. Scores range from 0 to 36, with higher scores indicating better verbal learning.",{"measure":67,"description":68,"timeFrame":56},"Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised","Delayed verbal memory will be measured as the number of words recalled after a delay on the Hopkins Verbal Learning Test-Revised. Scores range from 0 to 12, with higher scores indicating better delayed verbal memory.",{"measure":70,"description":71,"timeFrame":56},"Change in Language Function on the Western Aphasia Battery","Language function will be measured using the Western Aphasia Battery Aphasia Quotient. Scores range from 0 to 100, with higher scores indicating better language function.",{"measure":73,"description":74,"timeFrame":56},"Change in Story Recall on the Automatic Story Recall Test","Story recall will be measured using the Automatic Story Recall Test score. Scores will be reported as the percentage of story content correctly recalled, ranging from 0% to 100%, with higher scores indicating better story recall.",{"measure":76,"description":77,"timeFrame":56},"Change in Working Memory on the Digit Span Task","Working memory will be measured using the Digit Span Task total raw score. Scores range from 0 to 48 if using the WAIS-IV Digit Span version, with higher scores indicating better working memory.","ALL","22 Years",null,false,{"inclusion":83,"exclusion":93,"raw_text":102},[84,85,86,87,88,89,90,91,92],"Adults aged 22 years or older","History of stroke","Implanted with a Vivistim™ VNS device","Monolingual in English","Home-dwelling and independent in activities of daily living","No prior language training in the selected language of learning","Tolerated 6 weeks of movement therapy at 0.8 mA without incident and has used the device for at-home stimulation without incident","Willing and able to participate in a six-week at-home intervention","Clinically stable, without major concurrent medical conditions that would interfere with study participation",[94,95,96,97,98,99,100,101],"Severe aphasia","Unable to read and\u002For write in English","Significant uncorrected hearing or visual impairment","Unable to commit to 6 weeks of therapy","Pregnancy","Prisoner or ward of the state","Any medical condition that, in the investigator's judgment, would make participation unsafe","Younger than 22 years of age","Inclusion Criteria:\n\n* Adults aged 22 years or older\n* History of stroke\n* Implanted with a Vivistim™ VNS device\n* Monolingual in English\n* Home-dwelling and independent in activities of daily living\n* No prior language training in the selected language of learning\n* Tolerated 6 weeks of movement therapy at 0.8 mA without incident and has used the device for at-home stimulation without incident\n* Willing and able to participate in a six-week at-home intervention\n* Clinically stable, without major concurrent medical conditions that would interfere with study participation\n\nExclusion Criteria:\n\n* Severe aphasia\n* Unable to read and\u002For write in English\n* Significant uncorrected hearing or visual impairment\n* Unable to commit to 6 weeks of therapy\n* Pregnancy\n* Prisoner or ward of the state\n* Any medical condition that, in the investigator's judgment, would make participation unsafe\n* Younger than 22 years of age",[104,105],"ADULT","OLDER_ADULT",[107],{"facility":108,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Stony Brook University Hospital","Stony Brook","New York","11790","United States",{"lat":114,"lon":115},40.92565,-73.14094,[],[],[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[20],[],{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This interventional study plans to enroll 20 participants. Participants will be randomly assigned to either receive active VNS or a sham (inactive) stimulation during daily language-learning sessions.","completed","Vagus Nerve Stimulation for Cognition and Language Learning After Stroke","This study is investigating if Vagus Nerve Stimulation (VNS) can improve memory and language learning in people who have had a stroke. VNS is a treatment that involves sending mild electrical pulses to the vagus nerve. The study is for adults aged 22 or older who have already had a stroke, are monolingual in English, and have a Vivistim™ VNS device implanted. Participants will learn a new language, and researchers will measure how accurately they learn foreign language vocabulary and sentences at the beginning and after 6 weeks. The study aims to see if using the VNS device during language training can help with cognitive improvement.","Your foreign language learning accuracy will be measured at the beginning of the study and again after 6 weeks.",106,"You would participate in daily language-learning sessions over approximately six weeks. There may also be MRI\u002FfMRI scans at up to three different times.","Not stated in the trial record.",[],"v2"]