Vagal Nerve Stimulation To Enhance Cognition and Learning
17 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Foreign-Language Vocabulary Learning Accuracy
Periodo de tiempo: 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.
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Baseline and 6 weeks
|
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Change in Foreign-Language Sentence Learning Accuracy
Periodo de tiempo: 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.
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Baseline and 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: 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
|
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Change in Verbal Learning on the Rey Auditory Verbal Learning Test
Periodo de tiempo: 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
|
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Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change in Language Function on the Western Aphasia Battery
Periodo de tiempo: 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
|
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Change in Story Recall on the Automatic Story Recall Test
Periodo de tiempo: 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
Periodo de tiempo: 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.
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6 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change in Resting-State Functional Connectivity Between Language and Frontoparietal Cognitive-Control Networks
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de noviembre de 2025
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB2025-00209
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Marco de tiempo para compartir IPD
Within one year of study completion
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .