Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
研究概览
简要总结
The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •early-stage Alzhimer's disease and related dementias (ADRD)
- •have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10),
- •have a caregiver willing to participate in the study who sees the participant at least 10 hours/week
- •can speak and read English
- •have no plans to change medication regimens during the trial
排除标准
- •history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- •alcohol/substance abuse
- •severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)
- •hospitalization within the preceding year for neuropsychiatric illness
结局指标
主要结局
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
时间窗: baseline (day 1), end of intervention (day 5)
Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
次要结局
- Clinical Pain as Assessed by a Numerical Rating Scale (NRS)(baseline (day 1), end of intervention (day 5))
- Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)(baseline (day 1), end of intervention (day 5))
- Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)(baseline (day 1), end of intervention (day 5))
- Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System(baseline (day 1), end of intervention (day 5))
- Acceptability as Measured by the tDCs Experience Questionnaire(end of intervention (day 5))
- Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)(end of intervention (day 5))
研究者
Hyochol Ahn, PhD
Associate Dean for Research & Professor
Florida State University