Feasibility of combination exercise and neuromodulation rehabilitation to improve post-stroke chronic pain

联合运动和神经调节康复改善中风后慢性疼痛的可行性

基本信息

批准号：
10734040
负责人：
Chen Lin
金额：
--
依托单位：
BIRMINGHAM VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10734040
关键词：
Admission activity Adverse event Aerobic Exercise Aftercare American American Stroke Association Analgesics Brain Caring Chronic Classification Clinical Trials Cognition Contralateral Data Development Diagnosis Double-Blind Method Electromagnetics Eligibility Determination European Exercise Fatigue Future Goals Guidelines Headache Headache Disorders Heart Hospitalization Hour Inpatients International Intervention Ischemic Stroke Magnetism Measurement Measures Medical center Mental Depression Meta-Analysis Methods Modification Motor Cortex Neurologic Neurons Opioid Outcome Pain Participant Pathway interactions Patients Persons Pharmaceutical Preparations Physical activity Physical therapy Pilot Projects Precentral gyrus Preparation Procedures Quality of life Randomized Recommendation Recording of previous events Recovery Refractory Regimen Rehabilitation therapy Reporting Research Design Safety Site Stroke Stroke Belt Symptoms Syndrome Techniques Testing Therapeutic Uses Treatment outcome United States Veterans Work acute stroke arm associated symptom chronic pain chronic pain management cohort craving design disability efficacy study efficacy trial evidence based guidelines exercise intervention experience functional outcomes implementation intervention improved interest military veteran mortality neuroimaging neuroregulation pain outcome pain reduction pain score pain symptom painful neuropathy post stroke post stroke pain recruit repetitive transcranial magnetic stimulation safety and feasibility screening stroke incidence stroke outcome stroke survivor suicidal tool treatment effect

项目摘要

There are over 7 million stroke survivors in the United States. In the Veteran population, stroke is the leading cause of neurological disability, and one of leading causes of hospitalization. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post- stroke pain (PSP) can lead to further complications in a stroke survivor’s recovery. Exercise has been shown to improve pain symptoms of patients with PSP. the American Heart/Stroke Association recommended that exercise should be incorporated into the management of stroke survivors. Repetitive transcranial magnetic stimulation (rTMS) uses noninvasive cortical neurostimulation to improve neuropathic pain. A European commission to establish guidelines on therapeutic use of rTMS stated the evidence of rTMS of the contralateral primary motor cortex as definite analgesic effect with few safety issues (Level A recommendation). However, the effects of the treatment are transient, usually lasting a few hours to days[20]. While non- invasive, as a practical therapy for chronic PSP, more sustained efficacy of rTMS would be needed to be demonstrated. We hypothesize that pairing rTMS with exercise may develop a complementary effect to enhance the duration of symptomatic relief. This proposal is a single-site, randomized sham-controlled trial of rTMS and exercise in the treatment of Veterans with a diagnosis of chronic PSP who are at least 6-months from their cerebral stroke. The purpose of the pilot study is to evaluate the feasibility and safety of rTMS+exercise in Veterans diagnosed with chronic PSP. We will gather data to plan for a larger efficacy trial to assess sustained rTMS effects with exercise on pain outcomes. The long-term goal of the proposed work is to develop a non-pharmacologic intervention that also increases physical activity for patients suffering from chronic PSP. Following successful screening and baseline randomization, eligible patients will be treated with a regimen of rTMS vs sham rTMS for 1 week. Participants return for assessments at the end of week 1 and continue the assigned rTMS arm while adding supervised aerobic exercise 3 times weekly from week 2 to 9. Final assessment is at 3 months. Aim 1: Evaluate the feasibility of an efficacy study design comparing rTMS and exercise versus sham rTMS and exercise to reduce pain in patients with chronic PSP. Hypothesis 1: The pace of recruitment will be acceptable. We will recruit 36 patients, 32 of whom will complete the study within 3 months. Aim 2: Evaluate the safety of rTMS combined with aerobic exercise in patients with a history of ischemic stroke and chronic PSP. Hypothesis 2: Less than 10% of patients randomized to combined intervention of aerobic exercise plus rTMS will have adverse events and the observed rate will be comparable to patients randomized to aerobic exercise plus sham rTMS. Aim 3: To assess the correlation between neuronal connectivity of the motor cortex with pain and stroke outcomes following rTMS stimulation and aerobic exercise intervention in Veterans. Hypothesis 3: The measured strengthening of the structural and functional connectivity in the motor cortex following rTMS stimulation with the default mode network, limbic, and sensorimotor regions will be higher for the exercise plus rTMS compared with exercise plus sham rTMS (estimate only, without statistical testing).

美国有超过 700 万退伍军人中风幸存者。中风是导致神经功能障碍的主要原因，也是导致神经功能障碍的主要原因之一 10-50% 的中风幸存者可能会出现住院治疗。中风疼痛（PSP）可能会导致中风幸存者康复过程中出现进一步的并发症。已被证明可以改善美国心脏病/中风患者的疼痛症状。协会建议将运动纳入中风治疗中重复经颅磁刺激（rTMS）使用非侵入性皮质。欧洲委员会制定指南以进行神经刺激以改善神经性疼痛。关于 rTMS 的治疗用途指出了对侧初级运动的 rTMS 的证据皮质镇痛效果明确，安全性问题很少（A 级推荐）。治疗的效果是短暂的，通常持续几个小时到几天[20]。侵入性，作为慢性 PSP 的实用疗法，rTMS 的疗效更持久我们努力证明将 rTMS 与锻炼相结合可能会产生一种效果。互补作用可延长症状缓解的持续时间。该提案是一项针对 rTMS 和运动的单中心、随机假对照试验。治疗诊断为慢性 PSP 且距其治疗期限至少 6 个月的退伍军人试点研究的目的是评估脑卒中的可行性和安全性。诊断患有慢性 PSP 的退伍军人的 rTMS + 运动我们将收集数据以计划更大规模。评估运动对疼痛结果的持续 rTMS 效果的疗效试验。拟议工作的目标是开发一种非药物干预措施，该干预措施也可以增加成功筛查和治疗慢性 PSP 患者的体力活动。基线随机化，符合条件的患者将接受 rTMS 治疗方案与假 rTMS 治疗方案为期 1 周，参与者在第 1 周结束时返回进行评估并继续分配的任务。 rTMS 手臂，同时从第 2 周到第 9 周每周添加 3 次有监督的有氧运动。最终评估时间为3个月。目标 1：评估比较 rTMS 和运动与运动的功效研究设计的可行性假 rTMS 和运动可减轻慢性 PSP 患者的疼痛。假设1：招募速度是可以接受的，我们将招募36名患者，其中32名。谁将在3个月内完成研究。目标 2：评估 rTMS 联合有氧运动对有以下病史的患者的安全性缺血性中风和慢性 PSP。假设 2：不到 10% 的患者随机接受有氧运动联合干预运动加 rTMS 会产生不良事件，观察到的发生率与患者随机接受有氧运动加假 rTMS。目标 3：评估运动皮层的神经连接与疼痛和疼痛之间的相关性退伍军人经 rTMS 刺激和有氧运动干预后的中风结果。假设 3：结构和功能连通性的增强 rTMS 刺激后的运动皮层使用默认模式网络、边缘系统和与运动加相比，运动加 rTMS 的感觉运动区域会更高假 rTMS（仅估计，未经统计测试）。