Vagal Nerve Stimulation To Enhance Cognition and Learning
2026年7月17日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New York
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Stony Brook、New York、アメリカ、11790
- Stony Brook University Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：VNS Group
Group that was implanted with VNS and will receive stimulations
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Subjects previously implanted with VNS will undergo second language acquisition
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偽コンパレータ：Sham Group
Group that will receive sham stimulations
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Subjects previously implanted with VNS will undergo second language acquisition
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Foreign-Language Vocabulary Learning Accuracy
時間枠：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.
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Baseline and 6 weeks
|
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Change in Foreign-Language Sentence Learning Accuracy
時間枠：Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Global Cognition on the Montreal Cognitive Assessment (MoCA)
時間枠：6 weeks
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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.
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6 weeks
|
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Change in Verbal Learning on the Rey Auditory Verbal Learning Test
時間枠：6 weeks
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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
|
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Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test
時間枠：6 weeks
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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.
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6 weeks
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Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised
時間枠：6 weeks
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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
|
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Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised
時間枠：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.
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6 weeks
|
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Change in Language Function on the Western Aphasia Battery
時間枠：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.
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6 weeks
|
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Change in Story Recall on the Automatic Story Recall Test
時間枠：6 weeks
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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
|
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Change in Working Memory on the Digit Span Task
時間枠：6 weeks
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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.
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6 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Resting-State Functional Connectivity Between Language and Memory Networks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
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ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年11月17日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年6月26日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB2025-00209
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
Within one year of study completion
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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