Evaluation of Vagus Nerve Stimulation Paired With Cognitive Training to Enhance Learning and Memory and Neural Plasticity in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Foreign-Language Vocabulary Learning Accuracy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Foreign-Language Vocabulary Learning Accuracy
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change in Language Function on the Western Aphasia Battery(6 weeks)
- Change in Story Recall on the Automatic Story Recall Test(6 weeks)
- Change in Working Memory on the Digit Span Task(6 weeks)
研究者
Sima Mofakham
Associate Professor of Neurosurgery
Stony Brook University