Vagal Nerve Stimulation To Enhance Cognition and Learning
17 de julho de 2026 atualizado por: Sima Mofakham, Stony Brook University
Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients
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/fMRI 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/arousal, and frontoparietal cognitive-control networks.
The information learned may help guide future approaches to stroke rehabilitation and cognitive recovery.
Visão geral do estudo
Status
Inscrevendo-se por convite
Intervenção / Tratamento
Descrição detalhada
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.
Eligible 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.
The neuroimaging sub-study will include MRI/fMRI at up to three time points: pre-surgery baseline, when feasible before clinically indicated implantation; post-surgery/pre-language-training baseline; and post-training. The post-surgery/pre-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/arousal, frontoparietal cognitive control, and stroke recovery networks. A brief optional 0-back/1-back working-memory fMRI task may be included if scan time and participant tolerance allow.
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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Stony Brook, New York, Estados Unidos, 11790
- Stony Brook University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe aphasia
- Unable to read and/or 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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: VNS Group
Group that was implanted with VNS and will receive stimulations
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Subjects previously implanted with VNS will undergo second language acquisition
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Comparador Falso: Sham Group
Group that will receive sham stimulations
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Subjects previously implanted with VNS will undergo second language acquisition
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Foreign-Language Vocabulary Learning Accuracy
Prazo: Baseline and 6 weeks
|
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
|
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Change in Foreign-Language Sentence Learning Accuracy
Prazo: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Prazo: 6 weeks
|
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.
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6 weeks
|
|
Change in Verbal Learning on the Rey Auditory Verbal Learning Test
Prazo: 6 weeks
|
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.
|
6 weeks
|
|
Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test
Prazo: 6 weeks
|
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.
|
6 weeks
|
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Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised
Prazo: 6 weeks
|
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.
|
6 weeks
|
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Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised
Prazo: 6 weeks
|
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.
|
6 weeks
|
|
Change in Language Function on the Western Aphasia Battery
Prazo: 6 weeks
|
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.
|
6 weeks
|
|
Change in Story Recall on the Automatic Story Recall Test
Prazo: 6 weeks
|
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.
|
6 weeks
|
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Change in Working Memory on the Digit Span Task
Prazo: 6 weeks
|
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.
|
6 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Prazo: Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
Resting-state functional connectivity between predefined language and memory networks will be measured.
The outcome will be reported as change in Fisher z-transformed correlation coefficients between these networks.
Higher values indicate stronger functional connectivity.
|
Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
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Change in Resting-State Functional Connectivity Between Language and Salience/Arousal Networks
Prazo: Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
Resting-state functional connectivity between predefined language and salience/arousal networks will be measured.
The outcome will be reported as change in Fisher z-transformed correlation coefficients between these networks.
Higher values indicate stronger functional connectivity.
|
Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
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Change in Resting-State Functional Connectivity Between Language and Default Mode Networks
Prazo: Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
Resting-state functional connectivity between predefined language and default mode networks will be measured.
The outcome will be reported as change in Fisher z-transformed correlation coefficients between these networks.
Higher values indicate stronger functional connectivity.
|
Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
|
Change in Resting-State Functional Connectivity Between Language and Frontoparietal Cognitive-Control Networks
Prazo: Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
Resting-state functional connectivity between predefined language and frontoparietal cognitive-control networks will be measured.
The outcome will be reported as change in Fisher z-transformed correlation coefficients between these networks.
Higher values indicate stronger functional connectivity.
|
Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention
|
|
Change in Task-Based fMRI Activation During Foreign-Word Processing
Prazo: Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention.
|
Task-based fMRI activation will be measured during presentation of trained, future-trained, and never-trained foreign words.
The outcome will be reported as change in blood-oxygen-level-dependent activation, measured by contrast estimate or percent signal change, for trained and future-trained words compared with never-trained words.
Higher values indicate greater task-related activation.
|
Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de novembro de 2025
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
26 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de julho de 2026
Primeira postagem (Real)
22 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de julho de 2026
Última verificação
1 de janeiro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB2025-00209
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Prazo de Compartilhamento de IPD
Within one year of study completion
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Sim
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