Improving Functions in MTBI Patients with Headache by rTMS

通过 rTMS 改善 MTBI 头痛患者的功能

• 批准号: 9193558
• 负责人: ALBERT Y. LEUNG
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2016-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9193558
• 关键词: Adverse effects; Affective; Afghanistan; Analgesics; Area; Attention; Blast Cell; Blast Injuries; Brain; Chronic; Clinic; Clinical; Clinical Protocols; Clinical Services; Development; Diffuse; Disease; Dorsal; Favorable Clinical Outcome; Functional Magnetic Resonance Imaging; Functional disorder; Future; Headache; Health; Impaired cognition; Injury; Iraq; Lateral; Left; Maintenance; Memory; Microscopic; Modality; Moods; Neurobehavioral Manifestations; Neurologic; Neuronal Injury; Neurons; Outcome; Outcome Study; Pain; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Post-Traumatic Stress Disorders; Prefrontal Cortex; Prevention; Psychophysiologic Disorders; Randomized; Regimen; Rehabilitation therapy; Reporting; Research Personnel; Rest; Risk; Symptoms; Testing; Therapeutic; Treatment Cost; Veterans; War; central pain; combat; depressive symptoms; disturbance in affect; executive function; improved; improved functioning; mild traumatic brain injury; neuroimaging; neurophysiology; neuropsychological; novel; post stroke; repetitive transcranial magnetic stimulation; tool; treatment effect

DESCRIPTION (provided by applicant): Concussive or mild Traumatic Brain Injury (MTBI) related to blast injury is the most common form of combat-related injury in the Iraq and Afghanistan Wars. Along with post traumatic stress disorder (PTSD), cognitive and mood dysfunction, headache (HA) is the most debilitating clinical symptom in Veteran with MTBI. Unfortunately, conventional pharmacological treatments for MTBI related headache (MTBI-HA) has not shown to be effective and contain many long term untoward psychosomatic and abusive side effects. Recently, the use of non- invasive brain stimulation such as repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex(LDLPFC) has yielded favorable clinical outcomes in a few chronic central pain conditions including post-stroke central pain and headaches. In the past three years, the PI's clinical service has treated over 45 MTBI-HA Veteran with rTMS and observed favorable outcomes in headache relief and prevention. These benefits appear to be sustaujinable for a majority of patients with monthly repeated treatment. To further validate these observed favorable clinical outcomes, the investigators propose an initial randomized controlled project with the following main objectives: Aim #1: To compare the effect of active rTMS at LDLFC with sham rTMS in reducing the intensity and the duration of MTBI-HA; Aim #2: To compare the effect of active rTMS at LDLPFC with sham rTMS in improving cognitive and depressive symptoms associated with MTBI; In addition, to facilitate future studies in assessing the effect of repeat rTMS treatment at one month as an applicable clinical protocol and its effect on PTSD, and to further establishing the disease and therapeutic mechanisms related to MTBI-HA and rTMS respectively, the proposal also contains three exploratory aims: Exploratory Aim 1: In correlation with the headache and neurophysiological outcomes, this study will explore the effect of rTMS on supraspinal resting and evoked pain states in MTBI- HA patients with fMRI; Exploratory Aim 2: To explore the effect of maintenance rTMS for headache relief at the one-month interval after the initial treatments; Exploratory Aim 3: Since Headache, MTBI and Post-traumatic Stress Disorder (PTSD) are highly co-morbid conditions in Veterans, this study will explore the treatment effect of rTMS on alleviating functionally impairing conditions associated with PTSD(as identified with Clinician Administered PTSD Scale) in MTBI-HA Veterans. The proposed aims are closely interconnected and can be achieved without over- burdening both the Veteran and the investigators . Though these studies, the investigators aim to further develop rTMS as a non-invasive treatment tool for MTBI-HA and related neuropsychological dysfunctions, and enhance the understanding in MTBI related neurological mechanisms.

描述（由申请人提供）： 与爆炸伤相关的脑震荡或轻度创伤性脑损伤（MTBI）是伊拉克和阿富汗战争中最常见的战斗相关损伤形式。沿着创伤后应激障碍（PTSD）、认知和情绪障碍，头痛（HA）是退伍军人MTBI患者最常见的临床症状。不幸的是，MTBI相关头痛（MTBI-HA）的常规药物治疗尚未显示出有效性，并且包含许多长期不利的身心和滥用副作用。最近，在背外侧前额叶皮质（LDLPFC）处使用非侵入性脑刺激（例如重复经颅磁刺激（rTMS））在一些慢性中枢性疼痛病症（包括卒中后中枢性疼痛和头痛）中产生了有利的临床结果。在过去的三年里，PI的临床服务已经用rTMS治疗了超过45名MTBI-HA退伍军人，并观察到头痛缓解和预防的良好结果。这些益处对于大多数每月重复治疗的患者似乎是可持续的。为了进一步验证这些观察到的有利的临床结果，研究者提出了具有以下主要目的的初始随机对照项目：目的#1：比较在LDLFC的主动rTMS与假rTMS在降低MTBI-HA的强度和持续时间方面的效果;目的#2：比较在LDLPFC的主动rTMS与假rTMS在改善与MTBI相关的认知和抑郁症状方面的效果;此外，为了便于未来研究评估一个月重复rTMS治疗作为适用临床方案的效果及其对PTSD的影响，并进一步建立MTBI-HA和rTMS分别相关的疾病和治疗机制，该提案还包含三个探索性目标：探索性目标1：与头痛和神经生理学结局相关，本研究将通过fMRI探索rTMS对MTBI- HA患者的脊髓上静息和诱发疼痛状态的影响;探索性目的2：探索初始治疗后1个月间隔时维持rTMS对头痛缓解的影响;探索性目的3：由于头痛，MTBI和创伤后应激障碍（PTSD）是退伍军人的高度共病条件，本研究将探讨rTMS对减轻与PTSD相关的功能损害状况的治疗效果（根据临床医生管理的PTSD量表确定）。 拟议的目标是密切相关的，可以实现而不会给退伍军人和调查人员带来过重的负担。通过这些研究，研究人员旨在进一步开发rTMS作为MTBI-HA和相关神经心理功能障碍的非侵入性治疗工具，并增强对MTBI相关神经机制的理解。