TMS-fNIRS Personalized Dosing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Blinding Procedures The participants, PI, Research Staff involved in TMS treatment, and staff performing the study procedures will be blinded to the participant's dl-PFC protocol assignment throughout the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-70 years.
- •Eligible for consideration of treatment with TMS for PTSD.
- •Diagnosis of PTSD based on CAPS-
- •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.
- •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
排除标准
- •Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
- •Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
- •Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
- •Dementia or other cognitive disorder making unable to engage in study.
- •Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
- •Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
- •OCD cannot be the primary disorder but can have OCD symptoms
- •Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
- •Current, planned, or suspected pregnancy
- •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.)
- •Severe Traumatic Brain Injury
- •Prior TMS treatment or already received TMS as part of a study.
- •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.
研究组 & 干预措施
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.
干预措施: TMS-fNIRS over the dl-PFC (Device)
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.
干预措施: TMS-fNIRS over the dl-PFC (Device)
结局指标
主要结局
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
时间窗: 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.
次要结局
未报告次要终点
研究者
F. Andrew Kozel
Professor & Mina Jo Powell Endowed Chair, Neurological Sciences
Florida State University