NCT06645613

TMS With Real-time E-field and EEG Source Imaging

Precision TMS With Integrated Visualization and Analysis of Real-time E-field and EEG Source Imaging

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to develop and validate an approach for accurate targeting and stimulation of brain networks using transcranial magnetic stimulation (TMS) using information from magnetic resonance imaging (MRI) data. This study requires two visits from each participant. In the first visit, the participant will be scanned by MRI scanners to collect data from the brain. Next, the data will be analyzed by the researcher to model the connections between different regions of the brain to determine the stimulation areas related to the so-called frontoparietal network. In the second visit, the participants will take four TMS sessions with different types of stimulations applied to the computed targets and complete a computer-based task named multi-source interference task. Electroencephalogram (EEG) data will be collected during the TMS stimulations and tasks. The main hypothesis is that applying TMS stimulations to the brain targets reduces the response time and response error in the tasks.

Detailed description

The main goal of this study is to develop and validate an approach to target and stimulate brain networks using transcranial magnetic stimulation using information from magnetic resonance imaging (MRI). Participants in this study will first be scanned using an MRI scanner to collect data from the brain. The MRI session will take about 40 minutes to acquire anatomical MRI, diffusion MRI, and resting-state functional MRI from the subjects. Next, the researchers will analyze the MRI data to determine the stimulation areas of each participant. The method will provide two target areas in the brain, including an area in the left dorsolateral prefrontal cortex (DLPFC) and an area in the left inferior parietal lobule (IPL), which are involved in the frontoparietal network related to the executive control functions of the brain. In the second visit, the participants will take TMS stimulations to the determined brain targets at DLPFC and IPL. The standard intermittent theta-burst (iTBS) protocol will be applied to the targets. To evaluate the effect of TMS stimulations, the participants will perform a computer-based task, named multi-source interference task (MSIT), before the TMS stimulation and another task after the TMS stimulations. The participants will click mouse buttons to respond to instructions in the tasks. The response time and response error of the tasks will be the outcome measures of this study. The hypothesis is that applying TMS stimulations to the developed brain network targets reduces the response time and response error. During the TMS stimulations and tasks, electroencephalogram (EEG) data will be collected from the participants. The EEG data, MRI data, and TMS-induced electric field maps will be analyzed and visualized using a software named SlicerTMS. However, the information shown in SlicerTMS will not be used to change the stimulation protocol in this study.

Conditions

• Healthy Volunteers Only

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation Device	Transcranial magnetic stimulation uses FDA-approved coils to generate varying magnetic fields in the brain of the participant and induce an electric field in the underlying brain tissue. The standard intermittent Theta Burst Stimulation (iTBS) TMS protocol will be applied in this study. The same coil can be applied to generate sham stimulations that only generate sound and stimulations to the scalp without stimulating the brain.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-10-17
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study