Transcranial Magnetic Stimulation for the Treatment of Veterans with Alcohol Use Disorders

经颅磁刺激治疗患有酒精使用障碍的退伍军人

• 批准号: 10622442
• 负责人: TIMOTHY CRAIG DURAZZO
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10622442
• 关键词: Abstinence; Address; Alcohol consumption; Anterior; Anxiety; Biological Markers; Blood flow; Brain; Brain region; Chronic; Cigarette; Clinic; Cognitive; Consumption; Controlled Clinical Trials; Controlled Study; Data; Disease; Double-Blind Method; FDA approved; Frequencies; Functional disorder; Future; Glutamates; Glutamine; Goals; Health; Health Care Costs; Healthcare Systems; High Prevalence; Homelessness; Intervention; Left; Magnetic Resonance Imaging; Major Depressive Disorder; Measurement; Measures; Medical; Methods; Modality; Monitor; Moods; Neurobiology; Neurocognitive Deficit; Neuropsychology; Outcome Measure; Participant; Persons; Pharmacology; Procedures; Protocols documentation; Randomized Clinical Trials; Recovery; Recovery of Function; Relapse; Research; Resource Allocation; Sampling; Severities; Techniques; Telephone; Therapeutic; Tissues; Transcranial magnetic stimulation; Treatment Protocols; Treatment outcome; Unemployment; United States Department of Veterans Affairs; Veterans; alcohol abuse therapy; alcohol use disorder; cigarette smoking; clinically relevant; cost; craving; depressive symptoms; design; effective therapy; effectiveness evaluation; efficacy evaluation; experience; frontal lobe; innovation; novel; potential biomarker; psychosocial; recruit; repetitive transcranial magnetic stimulation; research study; sobriety; social relationships; standardize measure; substance abuse treatment; substance use; treatment group; treatment response

The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the DVA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD. rTMS is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and the disorders that commonly co-occur with AUD. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction and salient co-occurring conditions. Accordingly, additional rigorously controlled studies are required to determine if rTMS is an effective treatment for Veterans with AUD. Participants will be recruited from VA Palo Alto Health Care System (VAPAHCS) residential substance abuse treatment clinics A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) – will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders at the VAPAHCS MIRECC. Magnetic resonance imaging (MR) will be completed prior to rTMS treatment and used to localize the left DLPFC in each participant to optimize rTMS for this region. Active and Sham rTMS groups will complete predictive measures [i.e., MR measures of anterior frontal glutamate:glutamine ratio (Glx), blood flow and tissue volume] prior to the inception of rTMS treatment (baseline) and other outcome measures (i.e., measures of craving, mood, anxiety) immediately pre- and post-completion of the 2 weeks of rTMS sessions. Measurement of baseline anterior frontal Glx, blood flow levels, and tissue volumes is necessary to establish potential biomarkers for prediction of rTMS treatment response, which is requisite for therapeutic optimization. For the 6 months following completion of active or sham rTMS treatment, participants will be contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, as well as craving, to assess for changes in these variables over the previous 30 days. This project will deliver completely novel data on the efficacy of rTMS for Veterans with AUD during the first 6 months following treatment. Monitoring over the entire first 6 months following treatment is crucial, given relapse within the first 6 months of treatment is robustly related to poor psychosocial functioning over the ensuing 1-3 years. The ultimate goal of this proposal is provide treatment that more effectively promotes sustained abstinence in the Veteran with AUD, as extended abstinence is robustly associated with optimum biomedical, neuropsychological, psychiatric, and psychosocial recovery and functioning.

本研究的目的是评价重复经颅磁刺激（rTMS）的疗效 作为一种治疗退伍军人与酒精使用障碍（AUD），以降低极高的发病率， 与这种情况有关的复发。 至少60%的AUD患者将在治疗后6个月内经历一个主要的复发期， 无论采用何种干预措施（心理和/或药物）。因此，高 退伍军人中AUD的患病率和治疗后的复发与大量资源相关 DVA保健系统的拨款和费用。目前的药物和心理社会干预措施 仅表现出中等水平的疗效，这反映在AUD的高复发率中。 rTMS是一种处于创新、无创和安全治疗前沿的神经刺激方法 对于AUD，以及通常与AUD共同发生的疾病。降低退伍军人的高复发率 对于AUD，有必要进行干预，以更有效地解决相关的神经生物学问题。 功能障碍和显著的共同发生的条件。因此，额外的严格对照研究是 需要确定rTMS是否是AUD退伍军人的有效治疗。 参与者将从VA Palo Alto医疗保健系统（VAPAHCS）住宅物质中招募 一项双盲随机临床试验，分为两组：主动rTMS治疗组 （主动rTMS）-每周接受4至5次治疗（每天2次治疗），持续2周。假 对照治疗组（即，相同的rTMS实验程序，但没有主动刺激）将接受 rTMS会话的频率和持续时间相同。拟议的rTMS方案与FDA一致 VAPAHCS MIRECC批准的重度抑郁症治疗方案。磁 将在rTMS治疗前完成共振成像（MR），并用于定位每个患者的左侧DLPFC。 参与者优化该地区的rTMS。活动和假rTMS组将完成预测性测量 [i.e.,前额叶谷氨酸：谷氨酰胺比率（Glx）、血流量和组织体积的MR测量]。 rTMS治疗的开始（基线）和其他结果测量（即，渴望，情绪，焦虑的措施） 在2周rTMS课程完成前后立即进行。基线前部测量 额叶Glx、血流量水平和组织体积是建立潜在生物标志物进行预测所必需的 的rTMS治疗反应，这是必要的治疗优化。以下6个月 完成主动或假rTMS治疗后，将每月通过电话或电子邮件联系受试者 一个人，完成一个简短的标准化措施，酒精和物质的使用，以及渴望，以评估 这些变量在过去30天的变化。 该项目将在第一次试验期间提供关于rTMS对患有AUD的退伍军人的疗效的全新数据。 治疗后6个月。在治疗后的整个前6个月进行监测至关重要， 治疗前6个月内的复发与治疗后6个月内的不良心理社会功能密切相关。 随后的1-3年。该提案的最终目标是提供更有效地促进 AUD退伍军人的持续禁欲，因为延长禁欲与最佳 生物医学、神经心理学、精神病学和心理社会恢复和功能。