此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

TMS-fNIRS 个性化剂量

2026年11月2日 更新者:F. Andrew Kozel、Florida State University

The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.

Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)

研究概览

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Tallahassee、Florida、美国、32306
        • Isabelle Taylor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

  1. Adults ages 18-70 years.
  2. Eligible for consideration of treatment with TMS for PTSD.
  3. Diagnosis of PTSD based on CAPS-5.
  4. No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study.
  5. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

  1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
  2. Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
  3. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
  4. Dementia or other cognitive disorder making unable to engage in study.
  5. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
  6. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
  7. OCD cannot be the primary disorder but can have OCD symptoms
  8. Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
  9. Current, planned, or suspected pregnancy
  10. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
  11. Severe Traumatic Brain Injury
  12. Prior TMS treatment or already received TMS as part of a study.
  13. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).

We will exclude non-English speakers because of the need for rapid communication during the testing.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:TMS-fNIRS over the dl-PFC (Active)

TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols.

Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.

假比较器:TMS-fNIRS over the dl-PFC (Sham)

TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols.

Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
大体时间:Months 3-33

The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC.

Months 3-33

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.、Florida State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月19日

初级完成 (实际的)

2026年7月28日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2023年5月15日

首先提交符合 QC 标准的

2023年6月14日

首次发布 (实际的)

2023年6月23日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅