Home-based Transcranial Direct Current Stimulation for Pain Management in Persons with Alzheimers Disease

家庭经颅直流电刺激治疗阿尔茨海默病患者的疼痛

• 批准号: 10120073
• 负责人: Kenneth B Mathis
• 金额: $ 15.43万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10120073
• 关键词: Address; Adverse effects; Affect; Agitation; Alzheimer' s Disease; American; Analgesics; Anodes; Area; Behavior Disorders; Behavioral Symptoms; Blinded; Brain; Caregivers; Cathodes; Chronic; Clinic; Clinical; Clinical Trials; Cognitive; Confusion; Constipation; Contralateral; Data; Dementia; Development; Devices; Elderly; Ensure; Equipment and supply inventories; Future; Goals; Health Expenditures; Home environment; Individual; Intervention; Investigation; Knee Osteoarthritis; Memory; Modality; Morbidity - disease rate; Motor Cortex; Near-Infrared Spectroscopy; Pain; Pain management; Painless; Parents; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Phase; Population; Prevalence; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Research; Research Training; Risk; Secure; Self Administration; Supervision; System; Techniques; Testing; United States; United States Food and Drug Administration; Videoconferencing; base; behavior observation; chronic pain; clinical pain; comorbidity; design; evidence based guidelines; experience; falls; hemodynamics; improved; innovation; insight; interest; novel; osteoarthritis pain; pain processing; pain reduction; psychological symptom; real time monitoring; response; side effect; standard of care; symptom management; tool

ABSTRACT This Alzheimer’s-focused supplement will investigate the effects of home-based, remotely supervised transcranial direct current stimulation (tDCS) for pain management in persons with Alzheimer's disease (AD). The research proposed in this supplement aligns with the parent study (R15NR018050). The long-term goal of this supplement study is to improve pain management using home-based nonpharmacological approaches. AD is the most prevalent type of dementia, affecting 5.5 million individuals in the United States, and the management of pain is challenging because existing pharmacological approaches often produce significant adverse effects (e.g., constipation, confusion, behavioral disorders, psychomotor retardation, and falls). Also, recent evidence suggests that alterations in pain-related brain mechanisms may contribute to chronic pain. Therefore, innovative nonpharmacological interventions targeting pain-related brain function in persons with AD are needed. One promising pain treatment is tDCS with the anode over the primary motor cortex (M1) and the cathode over the contralateral supraorbital area (SO), as it can change brain activity in a noninvasive, painless, and safe way. tDCS is categorized by the FDA as a “non-significant risk” device. Moreover, home- based tDCS has been safely used to improve cognitive or memory problems among persons with AD and other dementias. However, no investigations to date have examined whether home-based tDCS can reduce pain. Home-based interventions are critical because persons with AD have difficulty attending clinic-based sessions over several days, and recent technological advances have created the potential for home interventions with real-time monitoring through a secure videoconferencing platform. The central hypothesis is that home-based, remotely supervised tDCS will decrease pain. This hypothesis will be tested by pursuing the following specific aims: evaluate the preliminary effects of home-based M1-SO applied tDCS on clinical pain in persons with early-stage AD (specific aim 1); evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage AD (specific aim 2); and evaluate the feasibility and acceptability of home-based M1-SO–applied tDCS for pain management in persons with early- stage AD (specific aim 3). We will also obtain data, as an exploratory aim, to investigate whether tDCS reduces behavioral and psychological symptoms of dementia. The proposed study will directly investigate the effects of home-based, remotely supervised tDCS in 40 persons with AD using an experimenter- and participant-blinded, randomized, sham-controlled, parallel group (1:1 for two groups) pilot clinical trial. Caregivers will set up and administer tDCS for persons with AD at home, and participants will be remotely supervised by trained research staff at each stimulation to ensure the use of proper technique. The proposed research is significant because it is expected to provide valuable insight into an exciting new modality of nonpharmacological pain management that is easy, safe, and noninvasive with minimal side effects.

摘要 这种以老年痴呆症为重点的补充将调查家庭为基础的，远程监督的影响 经颅直流电刺激（tDCS）用于阿尔茨海默病（AD）患者的疼痛管理。 本补充中拟定的研究与母研究（R15 NR 018050）一致。的长期目标 这项补充研究是为了改善疼痛管理使用家庭为基础的非药物的方法。AD 是最常见的痴呆症类型，影响美国550万人， 疼痛的管理是具有挑战性的，因为现有的药理学方法通常产生显著的 不利影响（例如，便秘、精神错乱、行为障碍、精神发育迟滞和福尔斯）。还有， 最近的证据表明，疼痛相关的大脑机制的改变可能有助于慢性疼痛。 因此，创新的非药物干预措施，针对疼痛相关的脑功能的人， AD是必须的。一种有希望的疼痛治疗是在初级运动皮层（M1）上使用阳极的tDCS， 对侧眶上区（SO）的阴极，因为它可以在非侵入性的情况下改变大脑活动， 无痛又安全的方法FDA将tDCS归类为“非重大风险”器械。此外，家- 基于tDCS已安全地用于改善AD患者的认知或记忆问题， 其他痴呆症然而，迄今为止，还没有调查研究家庭式tDCS是否可以减少 痛苦基于家庭的干预是至关重要的，因为AD患者很难参加基于诊所的 几天的会议，最近的技术进步创造了家庭的潜力， 通过安全的视频会议平台进行实时监测。核心假设是 在家远程监控的tDCS可以减轻疼痛这一假设将通过追踪 以下具体目的：评价家庭M1-SO应用tDCS对临床疼痛的初步效果， 患有早期AD的人（具体目标1）;评估应用的基于家庭的M1-SO的初步效果 tDCS对早期AD患者疼痛相关皮层反应的影响（具体目标2）;并评估 家庭M1-SO应用tDCS用于早期疼痛管理的可行性和可接受性， 阶段AD（具体目标3）。作为探索性目的，我们还将获得数据，以研究tDCS是否降低 痴呆症的行为和心理症状。拟议的研究将直接调查 在40名AD患者中，使用实验者和参与者盲法， 随机、假对照、平行组（两组1：1）初步临床试验。护理人员将设置和 在家中为AD患者管理tDCS，参与者将由训练有素的研究人员远程监督 每次刺激时都有工作人员，以确保使用正确的技术。这项研究意义重大，因为它 有望为非药物性疼痛管理的一种令人兴奋的新模式提供有价值的见解 简单、安全、无创、副作用小。