rTMS Clinical Trial for Auditory Hallucinations

rTMS 治疗幻听的临床试验

基本信息

批准号：
7343162
负责人：
RALPH Edward HOFFMAN
金额：
$ 42.48万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-02-01 至 2011-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7343162
关键词：
Acoustic Stimulation Algorithms Area Auditory Auditory Hallucination Auditory area Behavioral Brain Brain region Cerebrum Clinical Clinical Trials Cognitive Condition Daily Data Diagnosis Distant Distress Enrollment Equipment and supply inventories Follow-Up Studies Frequencies Functional Magnetic Resonance Imaging Functional disorder Generations Hallucinations Handedness Individual Inpatients Intervention Label Language Left Magnetic Resonance Imaging Maps Masks Measures National Institute of Mental Health Neuropsychological Tests Numbers Outcome Patients Persons Pharmaceutical Preparations Pilot Projects Play Positioning Attribute Prefrontal Cortex Preparation Principal Investigator Protocols documentation Public Health Quality of life Questionnaires Randomized Rate Relative (related person)Reporting Research Research Personnel Resistance Role Safety Schedule Schizoaffective Disorders Schizophrenia Score Series Severities Side Signal Transduction Site Speech Speech Perception Statistically Significant Superior temporal gyrus Surface Symptoms Syndrome Temporal Lobe Testing Translational Research Voice Week Wernicke Area base behavior measurement clinical efficacy design dosage experience falls follow-up functional disability insight neuropsychiatry programs repetitive transcranial magnetic stimulation response simulation speech processing

项目摘要

DESCRIPTION (provided by applicant): Studies suggest that speech processing areas of the brain play an important role in producing auditory hallucinations (AHs). The PI has reported that delivering 1-Hertz repetitive transcranial magnetic stimulation (rTMS) to the left temporoparietal cortex - a brain region underlying speech perception - produces statistically significant improvements in AHs relative to sham simulation. In a follow-up study, the PI used individualized fMRI maps of abnormal speech processing neurocircuitry to position rTMS in multiple cortical sites, and has found that targeting Wernicke's region and a homologous right-sided region in the superior temporal gyrus (STG) optimized clinical improvement of AHs. The proposed study will enroll 90 patients with a diagnosis of schizophrenia and medication-resistant AHs in a more extended, double- masked rTMS trial. Stimulation will be positioned using structural MRI over the left Wernicke's site and right-sided STG site previously found to have optimized clinical response. Specific Aim #1 is to demonstrate that MRI-positioned 1-Hz rTMS, delivered to the Wernicke's and right STG sites, each for 5 sessions in randomized order, results in greater clinical improvement in AHs compared to sham stimulation. Specific Aim #2 is to determine if alterations in cerebral laterality predict optimal hemisphere of stimulation in reducing AHs, and the degree of improvement elicited by rTMS at each of the two sites. Specific Aim #3 is to demonstrate that a third 5-session series of active rTMS directed to the left/right site found to optimize clinical improvement in the first 10 sessions produces greater improvements in AHs compared to sham stimulation positioned according to the same algorithm. Specific Aim #4 is to demonstrate prospectively that a higher level of hallucination frequency at baseline is a statistical moderator of 1-Hz rTMS in reducing AHs. This study will provide critical information regarding positioning strategies that optimize rTMS for AHs, as well as new insights regarding underlying pathophysiology.

描述（由申请人提供）：研究表明大脑的语音处理区域在产生幻听（AH）方面发挥着重要作用。 PI 报告称，向左颞顶皮层（负责言语感知的大脑区域）提供 1 赫兹重复经颅磁刺激 (rTMS)，相对于假模拟，AH 会产生统计上显着的改善。在后续研究中，PI 使用异常语音处理神经回路的个性化 fMRI 图将 rTMS 定位在多个皮质部位，并发现针对 Wernicke 区域和颞上回 (STG) 中的同源右侧区域优化了临床改善受影响户的情况。拟议的研究将招募 90 名被诊断为精神分裂症和耐药性 AH 的患者参加一项更广泛的双盲 rTMS 试验。将使用结构 MRI 将刺激定位在左侧 Wernicke 部位和右侧 STG 部位，此前发现这些部位具有优化的临床反应。具体目标 #1 是证明，与假刺激相比，将 MRI 定位的 1-Hz rTMS 传送到 Wernicke 和右侧 STG 部位（每个部位按随机顺序进行 5 个疗程）可带来更大的 AH 临床改善。具体目标#2 是确定大脑偏侧性的改变是否可以预测减少 AH 的最佳半球刺激，以及 rTMS 在两个部位引起的改善程度。具体目标 #3 是证明，与根据相同算法定位的假刺激相比，针对左/右部位的第三个 5 疗程系列的主动 rTMS 优化了前 10 疗程中的临床改善，可产生更大的 AH 改善。具体目标#4 是前瞻性地证明基线时较高水平的幻觉频率是 1-Hz rTMS 在减少 AH 方面的统计调节因素。这项研究将提供有关优化 AH rTMS 的定位策略的关键信息，以及有关潜在病理生理学的新见解。