Neuroimaging correlates and feasibility of transcranial magnetic stimulation (TMS) to improve smoking cessation outcomes in Veterans with comorbid PTSD
神经影像学相关性和经颅磁刺激 (TMS) 改善患有 PTSD 退伍军人戒烟结果的可行性
基本信息
- 批准号:10590175
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-07-01 至 2028-06-30
- 项目状态:未结题
- 来源:
- 关键词:AbstinenceAdultAffectAwardBrainCarbon MonoxideCause of DeathCessation of lifeChronicCigaretteClinicalClinical ResearchClinical TrialsCognitive TherapyConfidence IntervalsConsumptionDataDevelopmentDevicesDouble-Blind MethodEconomicsEligibility DeterminationEnrollmentEnsureExclusionExhalationFeasibility StudiesFunctional Magnetic Resonance ImagingGeneral PopulationGoalsGrantHealthHealthcareIndividualInsula of ReilInterventionKnowledgeLife ExpectancyMajor Depressive DisorderMeasuresMental HealthMental disordersMentorsMethodologyMethodsModalityNeuronavigationNeurosciencesOutcomeParticipantPharmacotherapyPhysiciansPopulationPost-Traumatic Stress DisordersPrefrontal CortexPreparationProceduresPsychotherapyPublic HealthRandomizedRandomized, Controlled TrialsResearchResearch TrainingResistanceRestRiskSamplingScientistSmokeSmokerSmokingSmoking Cessation InterventionStructureStructure of postcentral gyrusStudy SectionSubstance Use DisorderSystemTechniquesTestingTherapeuticTobacco Use DisorderTobacco smoking behaviorTobacco useTractionTrainingTraining SupportTranscranial magnetic stimulationTraumaUncertaintyUnited StatesUnited States Department of Veterans AffairsUnited States Food and Drug AdministrationVeteransVulnerable PopulationsWorkWritingacceptability and feasibilityactive comparatoralternative treatmentcareerclinical efficacycomorbiditydisabilityeffective therapyevidence baseexperiencefeasibility trialimprovedindependent component analysisinnovationinsightmulti-component interventionmultimodalityneuralneural circuitneural networkneuroimagingneuroregulationnicotine replacementnoninvasive brain stimulationnovelopen labelplacebo grouppoor health outcomerecruitrepetitive transcranial magnetic stimulationresearch studyretention rateskillssmoking abstinencesmoking cessationsmoking initiationsmoking prevalencesubstance usesubstance use treatmenttrauma exposuretreatment effecttrial comparingtrial design
项目摘要
Tobacco use remains the number one preventable cause of death in the United States. Unfortunately, individuals
with mental health conditions are disproportionately affected. Tobacco use is also high among US Veterans, and
those who have experienced trauma are even more likely to smoke. Successful quitting is especially difficult for
individuals who develop posttraumatic stress disorder (PTSD). Despite the efficacy of current evidence-based
pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed.
Neuroimaging techniques such as resting-state functional magnetic resonance imaging (rs-fMRI) have provided
insight into the neurocircuitry of tobacco use disorder (TUD) and successful quit attempts. Interventions that
modulate the neural systems underlying TUD, such as repetitive transcranial magnetic stimulation (rTMS), may be
critical to improving clinical outcomes. Indeed, the US Food and Drug Administration (FDA) recently cleared a form
of rTMS as a short-term smoking cessation treatment in adults. However, most clinical trials on rTMS for smoking
cessation have been conducted in civilian samples and have excluded individuals with psychiatric conditions. To
improve smoking cessation treatment options for Veterans with PTSD, it is critical to evaluate novel brain
stimulation methods such as rTMS in this vulnerable population. Furthermore, the development of neuroscience-
informed techniques to enhance rTMS such as neuronavigation based on rs-fMRI is critical to individualizing rTMS
for smoking cessation and understanding mechanisms of action. The application of neuroimaging to develop
personalized rTMS targets to precisely modulate targeted underlying neurocircuitry has been successfully applied
to the treatment of major depressive disorder (MDD). Similar methodology has been demonstrated successfully for
smoking cessation by the candidate’s mentors, but this work was completed in a sample of civilian participants
making a quit attempt who did not have psychiatric illness. To fill these knowledge gaps, the proposed research
aims to develop feasibility data for the therapeutic application individualized neuronavigated rTMS for Veterans
with PTSD attempting to quit smoking. Using a feasibility randomized controlled trial (RCT) design, eligible
Veterans with PTSD (n=50) seeking smoking cessation will receive rs-fMRI before and after a 5-day course of
neuronavigated rTMS the week prior to their quit date, in conjunction with nicotine replacement therapy (NRT) and
cognitive behavioral therapy (CBT). The scientific aims of the study are to evaluate feasibility of treatment delivery
procedures, develop preliminary effect size estimates, and demonstrate target engagement of the intervention
within neural networks critical to TUD. In addition, complementary training and mentoring plans will provide the
candidate with mentored clinical research training that supports the completion of the CDA-2 research study and
preparation a Merit Review award application. Specifically, the candidate will develop technical proficiency in rTMS
therapy and fMRI-based neuronavigation, proficiency in clinical trials, training, and experience in clinical research
domains relevant to Veteran health including PTSD and smoking cessation, and administrative, analytical and
grant writing skills. The proposed research study and training plan provide a platform for the candidate to develop
and implement a full RCT aimed at quantifying the efficacy of rs-fMRI-guided rTMS for smoking cessation in
Veterans with PTSD. Ultimately, this line of research will allow the candidate to establish independence as a
physician scientist at the Department of Veterans Affairs and to pursue a career on the development of non-
invasive neuromodulation treatments for Veterans with comorbid substance use and psychiatric disorders.
在美国,烟草的使用仍然是可预防的死亡原因。不幸的是,个人
在心理健康状况下受到不成比例的影响。美国退伍军人中的烟草使用也很高,
那些经历过创伤的人更有可能吸烟。成功的安静是特别困难的
患有创伤后应激障碍(PTSD)的个体。尽管目前基于证据的效率
药物治疗和戒烟的心理治疗,至关重要的是替代治疗。
神经影像学技术,例如静止状态功能磁共振成像(RS-FMRI)已提供
深入了解烟草使用障碍(TUD)和成功退出尝试的神经通路。干预措施
调节TUD的神经元系统,例如重复的经颅磁刺激(RTMS),可能是
对于改善临床结果至关重要。确实,美国食品药品监督管理局(FDA)最近清除了一种形式
RTMS作为成人的短期戒烟治疗。但是,大多数对吸烟的RTM的临床试验
停止在平民样本中进行了戒烟,并排除了具有精神病的人。到
改善PTSD退伍军人的戒烟治疗方案,评估新型大脑至关重要
在此脆弱人群中的RTM等刺激方法。此外,神经科学的发展 -
知情的技术以增强基于RS-FMRI的神经元行径等RTMS对于个体化RTMS至关重要
用于戒烟和理解作用机制。神经影像的应用
已成功应用的个性化RTMS目标已成功地使用了针对性的基础神经通路。
治疗主要抑郁症(MDD)。类似的方法已成功证明
候选人的导师戒烟,但是这项工作是在平民参与者样本中完成的
戒烟尝试没有精神病。为了填补这些知识空白,拟议的研究
旨在为退伍军人提供治疗应用个性化的神经宣传的RTM的可行性数据
PTSD试图戒烟。使用可行性随机对照试验(RCT)设计,符合条件
有PTSD(n = 50)寻求戒烟的退伍军人将在5天之前和之后获得RS-FMRI
神经脱位在退出日期之前的一周与尼古丁替代疗法(NRT)和
认知行为疗法(CBT)。该研究的科学目的是评估治疗的可行性
程序,制定初步效应尺寸估计并证明干预的目标参与
在TUD至关重要的神经网络中。此外,完整的培训和心理计划将提供
候选人进行了心理临床研究培训,该培训支持CDA-2研究的完成和
准备成绩审查奖申请。具体而言,候选人将在RTMS中发展技术水平
基于治疗和基于功能磁共振成像的神经元活动,临床试验的熟练程度,培训和临床研究经验
与退伍军人健康相关的领域,包括PTSD和戒烟,以及行政,分析和
授予写作技巧。拟议的研究和培训计划为候选人提供了一个平台
并实施旨在量化RS-FMRI引导RTMS戒烟的RS效率的完整RCT
具有PTSD的退伍军人。最终,这一研究将使候选人能够建立独立性
退伍军人事务部的医师科学家,并从事非 -
与合并药物使用和精神疾病的退伍军人的侵入性神经调节治疗。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Jonathan R Young其他文献
Electroconvulsive Therapy Changes Immunological Markers in Patients With Major Depressive Disorder: A Scoping Review.
电休克疗法改变重度抑郁症患者的免疫标志物:范围界定审查。
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:2.5
- 作者:
Jonathan R Young;Mariah K Evans;Julie Hwang;Michael D Kritzer;Charles H Kellner;Richard D. Weiner - 通讯作者:
Richard D. Weiner
Jonathan R Young的其他文献
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{{ truncateString('Jonathan R Young', 18)}}的其他基金
Neuroimaging correlates and feasibility of transcranial magnetic stimulation (TMS) to improve smoking cessation outcomes in veterans with comorbid PTSD
神经影像学相关性和经颅磁刺激 (TMS) 改善患有 PTSD 退伍军人戒烟结果的可行性
- 批准号:
10426251 - 财政年份:2021
- 资助金额:
-- - 项目类别:
Neuroimaging correlates and feasibility of transcranial magnetic stimulation (TMS) to improve smoking cessation outcomes in veterans with comorbid PTSD
神经影像学相关性和经颅磁刺激 (TMS) 改善患有 PTSD 退伍军人戒烟结果的可行性
- 批准号:
10261000 - 财政年份:2021
- 资助金额:
-- - 项目类别:
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