Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Hopkins Verbal Learning Test (Total Immediate Recall)
研究概览
简要总结
Decline in brain health and associated loss of cognitive function in healthy aging decreases quality of life.We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).
详细描述
Decline in brain health and associated loss of cognitive function in healthy aging decreases quality of life. We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. Auricular or transcutaneous vagal nerve stimulation (tVNS) is a low cost, easy to use, safe, and non-invasive approach for potentially enhancing brain systems important for cognition, neuroplasticity, and brain health.
The afferent path of the vagus travels through the nucleus of the solitary tract and the locus coeruleus, which both project to the hippocampus, a structure important in encoding new memories. The locus coeruleus is also the brain's primary source of norepinephrine. As the brain ages, there is a significant decline in the number and health of neurons, including in the pathway of the locus coeruleus. The release of norepinephrine in the medial temporal regions including the hippocampus, and the frontal lobes may enhance synaptic plasticity in critical cognitive areas and VNS upregulates norepinephrine.
The present proposal is designed to evaluate the pairing of cognitive training with transcutaneous vagal nerve stimulation (tVNS). The investigators have a collaborative relationship with the phase III Augmenting Cognitive Training (ACT) study team, which pairs a different non-invasive approach to brain stimulation (tDCS) with cognitive training. The investigators will leverage the existing ACT infrastructure developed through the support of NIA and the MBRF to evaluate tVNS and a cognitive training program in a two-week intervention with before and after cognition and multi-modal MRI assessments to determine brain function, plasticity, and cognitive modifications resulting from the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals willing to commit to study requirements
排除标准
- •Neurological disorders to include traumatic brain injury.
- •Evidence of dementia .
- •Major psychiatric illness
- •Unstable and chronic medical conditions.
- •MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
- •Physical impairment precluding motor response or lying still or walking
- •Hearing or vision deficits that will not allow for completion of assessments
研究组 & 干预措施
tVNS group
Participants will be randomly assigned to receive either active tVNS or sham stimulation during two weeks of cognitive training and will complete assessments before and after completion of this intervention. Participants in the tVNS group will undergo cognitive training paired with tVNS.
干预措施: Transcutaneous vagal nerve stimulation (tVNS) (Device)
tVNS group
Participants will be randomly assigned to receive either active tVNS or sham stimulation during two weeks of cognitive training and will complete assessments before and after completion of this intervention. Participants in the tVNS group will undergo cognitive training paired with tVNS.
干预措施: Cognitive training (Behavioral)
Sham group
Participants will be randomly assigned to receive either active tVNS or sham stimulation during two weeks of cognitive training and will complete assessments before and after completion of this intervention. Participants in the tVNS group will undergo cognitive training paired with sham stimulation.
干预措施: Cognitive training (Behavioral)
结局指标
主要结局
Hopkins Verbal Learning Test (Total Immediate Recall)
时间窗: At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).
The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. The total immediate recall score is the sum of correct words recalled after each of the 3 learning trials, which can range from 0 to 36.
Hopkins Verbal Learning Test (Total Delayed Recall)
时间窗: At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).
The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 12) after a 20-25 minute delay.
Hopkins Verbal Learning Test (Total Retention)
时间窗: At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).
The Hopkins Verbal Learning Test-Revised (HVLT-R) is a verbal learning and memory measure involving learning a 12-item word list across three learning trials followed by delayed recall after approximately 20-25 minutes. The Total Retention score is calculated by dividing the delayed recall score (range: 0-12) by the higher score from Learning Trial 2 or Learning Trial 3 (range: 0-12) and multiplying by 100 to yield the percentage of words retained following the delay period. Higher percentage scores indicate better retention of learned information. A score of 100% indicates that delayed recall performance was equal to the participant's best learning trial. Percentage scores greater than 100% are possible when delayed recall performance exceeds the participant's highest score on Learning Trial 2 or Learning Trial 3.
Hopkins Verbal Learning Test (Recognition)
时间窗: At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).
The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. Within the delayed yes-no recognition part of the task, the participant is presented with a larger list or words and responds to whether each was on the original 12-item list. The recognition discrimination index score is calculated as number of hits (correctly identified words from the list) - number of false positive words (incorrectly identified words that were not on the list), with scores ranging from 0 to 12 (perfect score).
NIH Toolbox Fluid Cognitive Composite
时间窗: At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).
The National Institutes of Health (NIH) Toolbox Fluid Cognition Composite is a standardized measure of fluid cognitive functioning derived from performance on five tests assessing attention, executive function, working memory, episodic memory, and processing speed (Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory, List Sorting Working Memory, and Pattern Comparison). Scores are reported as Fully Corrected T-scores derived from NIH Toolbox normative data and adjusted for demographic characteristics including age, sex, race/ethnicity, and education. Fully Corrected T-scores have a normative mean of 50 and standard deviation of 10. Higher T-scores indicate better fluid cognitive functioning, whereas lower T-scores indicate poorer fluid cognitive functioning. A T-score of 50 represents average performance relative to the normative population.
次要结局
未报告次要终点
