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临床试验/NCT06050603
NCT06050603招募中不适用

Spatiotemporally Precise Neuromodulation by Transcranial Magnetic Stimulation Guided by Multimodal Neuroimaging

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
2
主要终点
Response accuracy to psychological tasks

研究概览

简要总结

The goal of this interventional study is to develop an individualized approach using transcranial magnetic stimulation (TMS) in a high-precision manner. This approach will use TMS to modulate brain activity at multiple locations simultaneously. Functional magnetic resonance imaging (fMRI) and electroencephalograph (EEG) will record the responses and guide the stimulation. Specifically, the placement and orientation of TMS coils will be tailored to stimulate the targeted functional brain areas informed by fMRI. To maximize the interventional effect, stimulation pulses will be delivered based on EEG oscillations.

详细描述

Background:

Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses a transient electromagnetic field over a small area of the scalp to alter neuronal activity. It has been approved by Health Canada for the treatment of major depressive disorder and obsessive-compulsive disorder. Despite its clinical prevalence, TMS has a response rate of less than 50% and high intra- and inter-subject variability. Even among healthy subjects, the probability of inducing neuro-modulatory effects can be as low as 50%.

Design:

Depending on the study's aims, participants will have to visit Sunnybrook Health Sciences Centre two or three times on separate days. Participants will be screened with a medical record review before their first visit.

In the first visit, participants will have a magnetic resonance imaging (MRI) session. During the MRI session, participants will be brought inside an MRI scanner to collect images, including structural and functional MRI scans. During structural scans, participants will be asked to stay inside the MRI while images are taken. During functional MRI scans, participants will be asked to take rests with eyes open, watching and/or listening to audiovisual stimuli, and respond to stimuli by button pressing. Before starting MRI scans, a short training on the task will be taken. An additional assessment and, if necessary, training sessions will be conducted to ensure that participants undergo imaging while being able to keep their heads sufficiently for acceptable fMRI data quality. Before entering the MRI room, participants will be asked to remove any metal or magnetic sensitive objects (e.g., jewelry, keys, credit cards) to ensure safety. Earplugs or earphones will be provided to participants to reduce the loud noise produced by the MRI scanner. During the MRI scans, participants will perform the same task as notified in the training session. Short breaks will be arranged between tasks. The entire MRI procedure will take approximately one hour. If electroencephalograph (EEG) is to be recorded during MRI scans, an additional one hour is needed for EEG preparation before the MRI scans. After MRI scans, participants may be asked to rate their feelings toward the audiovisual stimuli, cognitive states, and emotional states on a computer.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

It is a within-subjects design, which means that all subjects will receive both individualized stimulation based on their functional results and generic stimulation based on the results of a meta-analysis.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Response accuracy to psychological tasks

时间窗: At baseline and immediately after treatment

accuracy, or rate of conditioned responses

Reaction times

时间窗: At baseline and immediately after treatment

Functional connectivity measured by fMRI

时间窗: At baseline and immediately after treatment

Functional connectivity during resting state and psychological tasks

次要结局

  • EEG functional connectivity(At baseline and immediately after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fa-Hsuan Lin

Senior scientist

Sunnybrook Health Sciences Centre

研究点 (2)

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