SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- N-Back Working Memory
研究概览
简要总结
The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). A precision dosing algorithm will be used to determine the appropriate levels of current and location of electrodes to deliver current using tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Procedures for tDCS will be identical for both arms with the exception of the amount of current delivered. Neither the participant nor the experimenter will know the amount of current delivered during tDCS sessions. Web-based permuted block randomization to randomly divide participants into the two groups.
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age: 65 to 89 years
- •English speaking
- •Physically mobile
- •Working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
排除标准
- •Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- •Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
- •Past opportunistic brain infection
- •Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
- •Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
- •MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
- •Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
- •Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
- •Hearing or vision deficits that will not allow for standardized cognitive training stimulation; ie colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
- •Left handedness, as those with left-handedness have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data.
- •Participants with precision tDCS dosage of >4.0mA required will be excluded due to limitations of tDCS device (maximum output of 4.0 mA). The maximum output of 4.0 mA reflects a technical limitation of the device design rather than a safety threshold.
结局指标
主要结局
N-Back Working Memory
时间窗: Baseline to post test. Post test will occur approximately two weeks following baseline.
Change in working memory performance on the N back working memory MRI task from baseline to post test will be assessed. Post test will occur approximately two weeks following baseline. The N-back working memory task will be completed during the MRI scan at both baseline and post test assessments. Working memory performance will be defined as a composite of reaction time and accuracy for two back trials. Specifically Target Accuracy percent correct and average correct target reaction time in milliseconds. Percent changes were calculated for Target Accuracy and Reaction Time in the form of (post test-pre test)/pre test. Since the direction of improvement is opposite for the two variables (i.e. higher Accuracy is better and lower Reaction Time is better), the reaction time percent change was multiplied by -1 to ensure a larger number indicated improved performance. To create a composite these two percent changes (Target Accuracy and Reaction Time) were averaged into a single value.
次要结局
未报告次要终点