Vagal Nerve Stimulation To Enhance Cognition and Learning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VNS for Cognition.
- Who it may be relevant to
- Registry conditions: Vagus Nerve Stimulation, Stroke, Cognitive Assessment, Language Acquisition. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients
Overview
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.
Detailed description
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.
Interventions
- Device VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition
Primary outcome measures
- Change in Foreign-Language Vocabulary Learning Accuracy [Time frame: Baseline and 6 weeks]
- Change in Foreign-Language Sentence Learning Accuracy [Time frame: Baseline and 6 weeks]
Secondary outcome measures (8)
- Change in Global Cognition on the Montreal Cognitive Assessment (MoCA) [Time frame: 6 weeks]
- Change in Verbal Learning on the Rey Auditory Verbal Learning Test [Time frame: 6 weeks]
- Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test [Time frame: 6 weeks]
- Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised [Time frame: 6 weeks]
- Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised [Time frame: 6 weeks]
- Change in Language Function on the Western Aphasia Battery [Time frame: 6 weeks]
- Change in Story Recall on the Automatic Story Recall Test [Time frame: 6 weeks]
- Change in Working Memory on the Digit Span Task [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University Hospital — Stony Brook
Identifiers
NCT: NCT07719387 · IRB2025-00209