Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645613
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
TMS with Real-time E-field and EEG Source Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision TMS with Integrated Visualization and Analysis of Real-time E-field and EEG Source Imaging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NetworkTMS
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None