Investigating the Effect of Cognitive Training with and Without Transcranial Alternating Current Stimulation on the Executive Brain Functions in Dementia Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.
研究概览
简要总结
This research investigates the effect of active versus sham tACS paired with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a one-time crossing over design in which participants are randomized into two groups: One group will receive active treatment for 4 weeks, then 8 weeks of no treatment followed by another 4 weeks of treatment but with sham. The other group will start with sham and end up with active treatment. The study is double-blind; thus, neither participants, nor the assessors know the group assignment.
The Intervention is applying tACS either active or sham paired with cognitive exercises (MindTriggers app games).
Note: The above study will run at both University of Manitoba (U of M) and Aster Gardens residence. However, at Aster Gardens Residence only questionnaire type of assessments will be run, while in U of M, the investigators will have three other major assessments as well. In addition, the investigators will run the assessments at the Aster Gardens Residence through online sessions.
详细描述
This research will investigate the effect of applying transcranial alternating current stimulation (tACS) when paired with cognitive exercises on older adults in a placebo-controlled double-blind study with statistical rigor. In addition, the investigators will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention but also to predict the response of a participant to the intervention at baseline. Since most technological intervention on dementia have a demanding and costly protocol, it would be of great interest to have a reliable prediction of a participant to a treatment at baseline; that would lead to personalized optimum treatment strategy. The investigators will use Electrovestibulography (EVestG), Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring and predicting technologies. EVestG is a non-invasive measure of the vestibuloacoustic system in both background (no motion) and in response to passive whole-body tilt stimuli. The investigators hypothesize there is a direct link between vestibular system deficiencies and Alzheimer's. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize it is deteriorated significantly in Alzheimer's even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The group assignment is known only by the study coordinator and the PI. Group assignment will be randomized into either Group 1 or Group 2 using PROC PLAN procedure of SAS randomization. The group assignment of a participant could potentially be unblinded on compassionate ground (e.g., if a participant comes from a different city for the duration of the study) or request of the participant or any emergency situation (although very rare). In that case the participant's data may be excluded from the analysis totally or depending on when this unblinding occur, half of the data might be usable for analysis (if unblinding occur during the waiting period before crossing over). The unblinding decision will be made by the PI.
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to read, write and speak English fluently
排除标准
- •Being diagnosed with Parkinson's, Parkinsonian dementia, Huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder
- •Having a History of epileptic seizures or epilepsy
- •Inability to adequately communicate in English
- •Impaired vision or hearing severe enough to impair performance in cognitive tests
- •Current substance abuse disorder
- •Currently participating in another therapeutic study for dementia
- •Plan to change the medication during this study's period
结局指标
主要结局
Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.
时间窗: Baseline (week 0), week 5, week 11, week 16
Cognitive and memory task that focus on 6 major memory indexes: Auditory Memory, Visual Memory, Visual Working Memory, Immediate Memory, Delayed Memory, and Recognition Memory.
次要结局
- N-back test(Baseline (week 0), week 5, week 11, week 16)
- Functional Near Infrared Spectroscopy (fNIRS)(Baseline (week 0), week 5, week 11, week 16)
- Electrovestibulography (EVestG)(Baseline (week 0), week 5, week 11, week 16)
- Virtual Reality Navigation (VRN) spatial orientation test(Baseline (week 0), week 5, week 11, week 16)
- Neuropsychiatric Inventory Questionnaire (NPIQ)(Baseline (week 0), week 5, week 11, week 16)
- Speech analysis(Baseline (week 0), week 5, week 11, week 16)
研究者
Dr. Zahra Kazem-Moussavi
Professor, Dept. of Electrical and Computer Eng. Director Biomedical Engineering
University of Manitoba