Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve

Medical University of South Carolina2 个研究点分布在 1 个国家目标入组 70 人开始时间: 2021年5月25日最近更新: 2025年12月2日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Medical University of South Carolina
入组人数: 70
试验地点: 2
主要终点: Depression severity (change in score)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

盲法说明

Study 1: All participants will be randomized to 10 different active doses of accelerated, intermittent theta burst rTMS.

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•A negative urine pregnancy test, if female subject of childbearing potential.
•Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
•After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.

排除标准

•Clinically unstable medical disease:
•cardiovascular
•gastrointestinal
•pulmonary
•metabolic
•endocrine
•CNS disease deemed progressive
•Moderate or severe traumatic brain injury (TBI)
•Pregnant females or those currently breast-feeding.
•Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:
•Alzheimer's disease
•other types
•Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.
•See further explanation under protection from risk.
•Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
•Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
•Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include:
•high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
•An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant).
•History of seizures or a seizure disorder.

研究组 & 干预措施

Dose 1

Experimental

All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.