Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT05665634
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent TMS and EEG Pilot Study
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Brain Stimulation and Electroencephalography Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the test-retest reliability of transcranial magnetic stimulation (TMS) -evoked potentials (TEPs) as measured by electroencephalography (EEG), using three different TMS protocols over five different brain regions in healthy volunteers. The goal is to compare the test-retest reliability of single pulse, inhibitory and excitatory TMS protocols as well as two distinct targeting approaches. The main questions to answer are:
1. This study will investigate whether the test-retest reliability of TEPs differ across TMS protocols.
2. This study will investigate whether the test-retest reliability of TEPs differ between individualized and non-individualized targeting approaches.
1. This study will investigate whether the test-retest reliability of TEPs differ across TMS protocols.
2. This study will investigate whether the test-retest reliability of TEPs differ between individualized and non-individualized targeting approaches.
Detailed Description:
Participants will first undergo functional magnetic resonance imaging (fMRI) scanning where structural and resting-state functional images will be obtained. In two separate sessions, participants will attend two concurrent TMS/EEG session with one week in between.
During the TMS/EEG sessions, an EEG cap will be placed on the participant's head and the resting motor threshold will be obtained to calibrate the TMS intensity required for the stimulation of target regions. Once setup procedures are complete, eleven total blocks of TMS with simultaneous EEG recording will take place. Among eleven blocks, five of will use single-pulse stimulation (to stimulate cortical excitation), three will use paired-pulse stimulation with 3ms between pulses (to stimulate cortical inhibition), and three will use paired-pulse stimulation with 11ms between pulses (to stimulate greater cortical excitation). Five different brain regions will be targeted: three individualized targets either derived anatomically (motor cortex) or based on the individual's resting-state functional connectivity (dorsolateral prefrontal cortex and angular gryus) and two regions that are based on the literature (dorsolateral prefrontal cortex and angular gryus).
During the TMS/EEG sessions, an EEG cap will be placed on the participant's head and the resting motor threshold will be obtained to calibrate the TMS intensity required for the stimulation of target regions. Once setup procedures are complete, eleven total blocks of TMS with simultaneous EEG recording will take place. Among eleven blocks, five of will use single-pulse stimulation (to stimulate cortical excitation), three will use paired-pulse stimulation with 3ms between pulses (to stimulate cortical inhibition), and three will use paired-pulse stimulation with 11ms between pulses (to stimulate greater cortical excitation). Five different brain regions will be targeted: three individualized targets either derived anatomically (motor cortex) or based on the individual's resting-state functional connectivity (dorsolateral prefrontal cortex and angular gryus) and two regions that are based on the literature (dorsolateral prefrontal cortex and angular gryus).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: