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Enrolling by Invitation

NCT Number: NCT07719387

Vagal Nerve Stimulation To Enhance Cognition and Learning

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.

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Key information

Conditions

Vagus Nerve Stimulation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognitive Assessment Language Acquisition Nervous System Diseases Stroke Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11790, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VNS for Cognition

Device

Subjects previously implanted with VNS will undergo second language acquisition

Primary outcomes

  1. Change in Foreign-Language Vocabulary Learning Accuracy

    Time frame: 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.

  2. Change in Foreign-Language Sentence Learning Accuracy

    Time frame: 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.

Secondary outcomes

  1. Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  2. Change in Verbal Learning on the Rey Auditory Verbal Learning Test

    Time frame: 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.

  3. Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test

    Time frame: 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.

  4. Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised

    Time frame: 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.

  5. Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised

    Time frame: 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. Change in Language Function on the Western Aphasia Battery

    Time frame: 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.

  7. Change in Story Recall on the Automatic Story Recall Test

    Time frame: 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.

  8. Change in Working Memory on the Digit Span Task

    Time frame: 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.

Other outcomes

  1. Change in Resting-State Functional Connectivity Between Language and Memory Networks

    Time frame: 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.

  2. Change in Resting-State Functional Connectivity Between Language and Salience/Arousal Networks

    Time frame: 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.

  3. Change in Resting-State Functional Connectivity Between Language and Default Mode Networks

    Time frame: 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.

  4. Change in Resting-State Functional Connectivity Between Language and Frontoparietal Cognitive-Control Networks

    Time frame: 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.

  5. Change in Task-Based fMRI Activation During Foreign-Word Processing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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