Vagus Nerve StimulationNCT07719387
Vagal Nerve Stimulation To Enhance Cognition and Learning
A study testing VNS for Cognition in people with Vagus Nerve Stimulation and Stroke, run by Stony Brook University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Vagus Nerve Stimulation, Stroke, Cognitive Assessment
- What is being tested?
- VNS for Cognition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11790
About this study
Official title: 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.
Read the 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.
- Being tested
- VNS for Cognition
- Keywords
- VNS, VNS for learning and cognition, stroke rehabilitation, fMRI, neuromodulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNS for CognitionDevice
Subjects previously implanted with VNS will undergo second language acquisition
| Study group | Role | What they receive |
|---|---|---|
| VNS Group | Active comparator | Group that was implanted with VNS and will receive stimulations Receives: Device: VNS for Cognition |
| Sham Group | Sham comparator | Group that will receive sham stimulations Receives: Device: VNS for Cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foreign-Language Vocabulary Learning Accuracy
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.
Measured: Baseline and 6 weeks
Change in Foreign-Language Sentence Learning Accuracy
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.
Measured: Baseline and 6 weeks
Secondary outcomes (8)
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
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.
Measured: 6 weeks
Change in Verbal Learning on the Rey Auditory Verbal Learning Test
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.
Measured: 6 weeks
Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test
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.
Measured: 6 weeks
Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised
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.
Measured: 6 weeks
Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised
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.
Measured: 6 weeks
Change in Language Function on the Western Aphasia Battery
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.
Measured: 6 weeks
Change in Story Recall on the Automatic Story Recall Test
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.
Measured: 6 weeks
Change in Working Memory on the Digit Span Task
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sima Mofakham, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719387
- Sponsor's protocol ID
- IRB2025-00209
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07719387
- Acronym / sponsor ID
- IRB2025-00209
- Keywords
- VNS, VNS for learning and cognition, stroke rehabilitation, fMRI, neuromodulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Group | Active comparator | Device: VNS for CognitionGroup that was implanted with VNS and will receive stimulations |
| Sham Group | Sham comparator | Device: VNS for CognitionGroup that will receive sham stimulations |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNS for CognitionSubjects previously implanted with VNS will undergo second language acquisition | Device | Sham Group, VNS Group |
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNS for Cognition in people with Vagus Nerve Stimulation and Stroke, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foreign-Language Vocabulary Learning Accuracy (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.