Personalized Closed-Loop Brain Stimulation for Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists
研究概览
简要总结
This research study investigates the feasibility and efficacy of a personalized, closed-loop electroencephalogram-transcranial electrical stimulation (EEG-tES) intervention for individuals with mild cognitive impairment (MCI), addressing the inconsistent results of generic brain stimulation protocols. By integrating artificial intelligence (AI)-derived insights with real-time data, the study aims to customize transcranial electrical stimulation (tES) parameters, including electrode placement, intensity, and frequency to target the specific brain regions responsible for abnormal signaling in each participant. Over the intervention period paired with computerized cognitive training, the project will evaluate improvements in learning, memory, and functional connectivity, while simultaneously identifying clinical and physiological predictors to determine the viability of transitioning this low-cost, non-invasive technology into a remotely supervised, home-based therapy setting. The study duration will be a total of 6-8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between 45-85 years of age.
- •Must be proficient in English.
- •Must have a minimum of high-school education.
- •Must be diagnosed with 'probable Alzheimer's Disease (AD)' in specialized diagnostic centers with neuropsychological (e.g., RAVLT) and AD biomarkers according to 2011 guidelines.
- •The investigators will also perform extensive testing in the investigators' test battery including the Mnemonic Similarity Test (MST) that discriminates and measures the most salient hippocampal deficit-pattern separation (PS).
排除标准
- •People with previous neurological disease including vascular dementia (e.g., stroke, developmental dyslexia, dysgraphia or attentional deficit).
- •People with hearing loss (> 25 decibel, using audiometric hearing screen).
- •People with uncorrected visual acuity loss.
- •People with advanced dementia or severe language impairments (MMSE <15, or Montreal Cognitive Assessment <10, or language Frontotemporal Dementia-specific Clinical Dementia Rating (FTD-CDR) =3).
- •People with pre-existing psychiatric disorders such as behavioral disturbances, severe depression, or schizophrenia that do not allow these people to comply or follow the study schedule and requirements such as repeated evaluation and therapy.
研究组 & 干预措施
Personalized closed-loop tES treatment + Cognitive Interventions
Participants will receive personalized, closed-loop active tES for 3 weeks. Active tES will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tES and will take approximately 30 minutes to complete.
干预措施: Active tES (Device)
Personalized closed-loop tES treatment + Cognitive Interventions
Participants will receive personalized, closed-loop active tES for 3 weeks. Active tES will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tES and will take approximately 30 minutes to complete.
干预措施: Cognitive Interventions (Behavioral)
结局指标
主要结局
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each trained word-list (practiced during the intervention period) will consist of 12 semantically related words (e.g., birds). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to learn each list. The investigators will compute the raw score of items correctly recalled by summing all scores from Trial 1 to Trial 5 and transforming to percent correct (range: 0-100%) at each time point of the study. Higher score is better. Increase in scores is considered a benefit.
Change in auditory delayed recall accuracy of semantically related - trained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each trained word-list (practiced during the intervention period) will consist of 12 semantically related words (e.g., birds). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to recall each list, and then participants will be asked to recall that list 20 minutes later (delayed recall). The investigators will compute the raw score of items correctly recalled (delayed recall) and transform to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit.Higher score is better.
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - trained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each trained word-list (practiced during the intervention period) will consist of 12 semantically unrelated words as in Rey Auditory-Verbal Learning Test (RAVLT). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to learn each list. The investigators will compute the raw score of items correctly recalled by summing all scores from Trial 1 to Trial 5 and transforming to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each trained word-list (practiced during the intervention period) will consist of 12 semantically unrelated words (as in RAVLT). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to recall each list, and then participants will be asked to recall that list 20 minutes later (delayed recall). The investigators will compute the raw score of items correctly recalled (delayed recall) and transform to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
Change in auditory recall accuracy based the sum of words recalled in Trials 1-5 of semantically related - untrained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each untrained word-list (not practiced during the intervention period) will consist of 12 semantically related words (e.g., birds). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to learn each list. The investigators will compute the raw score of items correctly recalled by summing all scores from Trial 1 to Trial 5 and transforming to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
Change in auditory delayed recall accuracy of semantically related - untrained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each untrained word-list (not practiced during the intervention period) will consist of 12 semantically related words (e.g., birds). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to recall each list, and then participants will be asked to recall that list 20 minutes later (delayed recall). The investigators will compute the raw score of items correctly recalled (delayed recall) and transform to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - untrained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each untrained word-list (not practiced during the intervention period) will consist of 12 semantically unrelated words (as in RAVLT). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to learn each list. The investigators will compute the raw score of items correctly recalled by summing all scores from Trial 1 to Trial 5 and transforming to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
Change in auditory delayed recall accuracy of semantically unrelated - untrained word-lists
时间窗: Before intervention, immediately after intervention and 1 month post intervention
Each untrained word-list (not practiced during the intervention period) will consist of 12 semantically unrelated words (as in RAVLT). Word lists will be constructed using psycholinguistic databases. There will be 5 Trials to recall each list, and then participants will be asked to recall that list 20 minutes later (delayed recall). The investigators will compute the raw score of items correctly recalled (delayed recall) and transform to percent correct (range: 0-100%) at each time point of the study. Increase in scores is considered a benefit. Higher score is better.
次要结局
- Change in Rey Auditory-Verbal Learning Test (RAVLT) score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in Mini Mental State Examination (MMSE)(Before intervention, immediately after intervention and 1 month post intervention)
- Change in Mnemonic Similarity Task (MST) score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in word repetition score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in non-word repetition score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in sentence repetition score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in oral naming Boston Naming Test score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in oral naming Philadelphia Naming Test score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in written naming as assessed by Boston Naming Test(Before intervention, immediately after intervention and 1 month post intervention)
- Change in written naming as assessed by Philadelphia Naming Test(Before intervention, immediately after intervention and 1 month post intervention)
- Change in oral naming of action as assessed by Hopkins Assessment of Naming Actions (HANA)(Before intervention, immediately after intervention and 1 month post intervention)
- Change in syntactic comprehension as assessed by Subject-relative, Object-relative, Active, Passive (S.O.A.P.) Syntactic Battery(Before intervention, immediately after intervention and 1 month post intervention)
- Change in verbal fluency task score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in spelling as assessed by the Johns Hopkins Dysgraphia battery(Before intervention, immediately after intervention and 1 month post intervention)
- Change in digit span forward score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in digit span backward score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in spatial span forward score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in spatial span backward score(Before intervention, immediately after intervention and 1 month post intervention)
- Change in semantic content of connected speech (Cookie Theft)(Before intervention, immediately after intervention and 1 month post intervention)
- Change in semantic content of connected speech (Circus)(Before intervention, immediately after intervention and 1 month post intervention)
- Change in attention and manipulation of information scores(Before intervention, immediately after intervention and 1 month post intervention)