Vagal Nerve Stimulation To Enhance Cognition and Learning

NCT07719387 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: IRB2025-00209
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vagus Nerve Stimulation; Stroke; Cognitive Assessment; Language Acquisition

Keywords

VNS; VNS for learning and cognition; stroke rehabilitation; fMRI; neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 6 weeks

Secondary Outcomes (8)

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

  6 weeks

• Change in Verbal Learning on the Rey Auditory Verbal Learning Test

  6 weeks

• Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test

  6 weeks

• Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised

  6 weeks

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

  6 weeks

Other Outcomes (5)

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

  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

  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

  Pre-surgery baseline, post-surgery/pre-training baseline, and immediately after the 6-week language-training intervention

Study Arms (2)

VNS Group

ACTIVE COMPARATOR

Group that was implanted with VNS and will receive stimulations

Device: VNS for Cognition

Sham Group

SHAM COMPARATOR

Group that will receive sham stimulations

Device: VNS for Cognition

Interventions

VNS for Cognition DEVICE

Subjects previously implanted with VNS will undergo second language acquisition

Sham Group; VNS Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11790, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 22, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within one year of study completion

Locations

US (1)