The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Immediate change in gait speed
研究概览
简要总结
The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in age-matched controls. In this population the DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.
In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.
The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.
详细描述
tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk.
Pre- and post-tDCS assessments will include:
Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015; Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.
Fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.
Cognitive assessment: A detailed computerized cognitive battery that has been used extensively at TASMC in different cohorts [Dwolatzky et al. 2003;Hausdorff et al. 2006;Springer et al. 2006;Yogev et al. 2005;Aarsland et al. 2003] will quantify several cognitive domains including working memory, executive function, verbal function, problem solving, a global cognitive score, and attention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 65-85 years,
- •ability to walk for 6 minutes unassisted,
- •adequate vision capabilities, and
- •stable medications for the past month.
排除标准
- •diagnosis of stroke, Parkinson's disease, peripheral neuropathy or other neurologic disorder,
- •lower-extremity deformity, joint replacement, severe arthritis or other diagnosed musculoskeletal disorder that may influence gait,
- •orthostatic hypotension, recent history of syncope or vertigo,
- •myocardial infarction or surgery within the past 6 months,
- •any unstable medical condition,
- •psychiatric co-morbidity (e.g., major depressive disorder as determined by DSM V criteria),
- •likely dementia (i.e., Mini Mental State Exam score < 24 or based on DSM V),
- •sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants,
- •colorblindness (confounder for cognitive assessment), or
- •contraindications to tDCS
研究组 & 干预措施
tDCS
The active tDCS condition will consist of 4 visit:
During each visit, subject will receive a single 20-minute session targeting the prefrontal cortices of either real (1.5 mA) or sham tDCS. Total 4 different targets:
- Sham
- motor M1 area
- motor M1 + Dorsolateral Prefrontal cortex
- Dorsolateral Prefrontal cortex.
The tDCS condition will be randomized and double blinded
干预措施: tDCS (Device)
结局指标
主要结局
Immediate change in gait speed
时间窗: 1st measure will be taken at baseline ans 2nd immediate post intervention
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
次要结局
- Changes in cognitive performance - Executive Function composite score(1st measure will be taken at baseline ans 2nd immediate post intervention)
- fNIRS related frontal lobe activation - changes in tissue oxygenation(1st measure will be taken at baseline ans 2nd immediate post intervention)
研究者
michal roll
Director of Research and Development
Tel-Aviv Sourasky Medical Center