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Vagal Nerve Stimulation To Enhance Cognition and Learning

17 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • Stony Brook, New York, Verenigde Staten, 11790
        • Stony Brook University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: VNS Group
Group that was implanted with VNS and will receive stimulations
Apparaat: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition
Sham-vergelijker: Sham Group
Group that will receive sham stimulations
Apparaat: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Foreign-Language Vocabulary Learning Accuracy
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Tijdsspanne: 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
Change in Resting-State Functional Connectivity Between Language and Salience/Arousal Networks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Stony Brook University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 november 2025

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

22 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB2025-00209

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD-tijdsbestek voor delen

Within one year of study completion

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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