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Vagal Nerve Stimulation To Enhance Cognition and Learning

17 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • New York
      • Stony Brook, New York, Stany Zjednoczone, 11790
        • Stony Brook University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: VNS Group
Group that was implanted with VNS and will receive stimulations
Urządzenie: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition
Pozorny komparator: Sham Group
Group that will receive sham stimulations
Urządzenie: VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Foreign-Language Vocabulary Learning Accuracy
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Resting-State Functional Connectivity Between Language and Memory Networks
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Stony Brook University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 listopada 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 lipca 2026

Pierwszy wysłany (Rzeczywisty)

22 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 lipca 2026

Ostatnia weryfikacja

1 stycznia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB2025-00209

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Ramy czasowe udostępniania IPD

Within one year of study completion

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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