Vagal Nerve Stimulation To Enhance Cognition and Learning
17 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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New York
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Stony Brook, New York, États-Unis, 11790
- Stony Brook University Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: VNS Group
Group that was implanted with VNS and will receive stimulations
|
Subjects previously implanted with VNS will undergo second language acquisition
|
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Comparateur factice: Sham Group
Group that will receive sham stimulations
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Subjects previously implanted with VNS will undergo second language acquisition
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Foreign-Language Vocabulary Learning Accuracy
Délai: 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
|
|
Change in Foreign-Language Sentence Learning Accuracy
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Délai: 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.
|
6 weeks
|
|
Change in Verbal Learning on the Rey Auditory Verbal Learning Test
Délai: 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
Délai: 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
|
|
Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
|
Change in Working Memory on the Digit Span Task
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Délai: 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
Délai: 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
|
|
Change in Resting-State Functional Connectivity Between Language and Default Mode Networks
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 novembre 2025
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
26 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB2025-00209
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Délai de partage IPD
Within one year of study completion
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .