Vagal Nerve Stimulation To Enhance Cognition and Learning
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: VNS for Cognition.
- Кому может быть актуально
- Состояния в реестре: Vagus Nerve Stimulation, Stroke, Cognitive Assessment, Language Acquisition. Базовые параметры: от 22 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство VNS for Cognition
Subjects previously implanted with VNS will undergo second language acquisition
Первичные конечные точки
- Change in Foreign-Language Vocabulary Learning Accuracy [Срок оценки: Baseline and 6 weeks]
- Change in Foreign-Language Sentence Learning Accuracy [Срок оценки: Baseline and 6 weeks]
Вторичные конечные точки (8)
- Change in Global Cognition on the Montreal Cognitive Assessment (MoCA) [Срок оценки: 6 weeks]
- Change in Verbal Learning on the Rey Auditory Verbal Learning Test [Срок оценки: 6 weeks]
- Change in Delayed Verbal Memory on the Rey Auditory Verbal Learning Test [Срок оценки: 6 weeks]
- Change in Verbal Learning on the Hopkins Verbal Learning Test-Revised [Срок оценки: 6 weeks]
- Change in Delayed Verbal Memory on the Hopkins Verbal Learning Test-Revised [Срок оценки: 6 weeks]
- Change in Language Function on the Western Aphasia Battery [Срок оценки: 6 weeks]
- Change in Story Recall on the Automatic Story Recall Test [Срок оценки: 6 weeks]
- Change in Working Memory on the Digit Span Task [Срок оценки: 6 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Stony Brook University Hospital — Stony Brook
Идентификаторы
NCT: NCT07719387 · IRB2025-00209