Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Vagal Nerve Stimulation To Enhance Cognition and Learning

17. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • Stony Brook, New York, Vereinigte Staaten, 11790
        • Stony Brook University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: VNS Group
Group that was implanted with VNS and will receive stimulations
Gerät: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition
Schein-Komparator: Sham Group
Group that will receive sham stimulations
Gerät: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Foreign-Language Vocabulary Learning Accuracy
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stony Brook University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. November 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juli 2026

Zuerst gepostet (Tatsächlich)

22. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Juli 2026

Zuletzt verifiziert

1. Januar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB2025-00209

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

IPD-Sharing-Zeitrahmen

Within one year of study completion

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren