Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
研究概览
简要总结
This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.
详细描述
This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind, sham controlled
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (Ps)
- •willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- •able and willing to comply with all study requirements
- •an informed consent form was signed
- •able to read, write, and communicate in English
- •Caregiver/Administrators (As)
- •at least 18 years of age
- •able to read, write, and communicate in English
- •self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?"
- •stated availability during weekdays throughout the study period to administer tES to the Ps
排除标准
- •Participants (Ps)
- •major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- •blindness or other disabilities that prevent task performance
- •contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.)
- •the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
- •an inability to understand study procedures following review of the Informed Consent form
- •Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator
- •Caregiver/Administrators (As)
- •mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
- •insufficient understanding of study procedures following review of the Informed Consent form
- •Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- •poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES
研究组 & 干预措施
tACS(AG) + tDCS(PFC) combo active
Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
干预措施: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) (Device)
tACS(AG) active + tDCS(PFC) sham
Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
干预措施: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham) (Device)
tACS(AG) sham + tDCS(PFC) active
Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
干预措施: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active) (Device)
tACS(AG) sham + tDCS(PFC) sham
Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
干预措施: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham) (Device)
结局指标
主要结局
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
时间窗: baseline, immediate post-intervention, 3 month follow up , 6 month follow up
This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15.
Change in Dual Task Cost to Gait
时间窗: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
This measure is captured by Mobility Lab™ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)\*100). Range for dual task cost is as follows: High Risk for falls \> 0.2, Moderate Risk for falls \<= 0.2, Low Risk \< 0.1.
次要结局
- Change in Functional Activity Questionnaire(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Average E-field normal component (En) for left angular gyrus and prefrontal cortex(immediate post-intervention)
- Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Adjusted Trail Making Test performance(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Stroop test response latency(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Gait speed(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Stride time variability(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Short Physical Performance Battery total score(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in 12-item Short Form Health Survey (SF-12)(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)
- Change in Average daily step count(baseline, immediate post-intervention, 3 month follow up, 6 month follow up)