Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633913
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Concurrent TMS-fMRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neural Effects of Transcranial Magnetic Stimulation Using Concurrent Functional Magnetic Resonance Imaging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The goal of this clinical trial is to examine the neural mechanisms underlying transcranial magnetic stimulation TMS using concurrent functional magnetic resonance imaging fMRI in both healthy controls HCs and patients with high negative affect symptoms such as depression and anxiety Approximately half male and half female participants aged 18-65 will be recruited
The main questions it aims to answer are
1 Is the acutetransient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS rTMS
2 Do any of these effects predict negative affect symptoms such as depression and anxiety
Participants will
1 Complete several tests to assess their cognitive abilities and emotional states
2 Undergo several brain scans including resting-state fMRI structural MRI diffusion tensor imaging DTI and task fMRI
3 Have two different types of TMS sequences single-pulse and repetitive pulses administered to specific brain regions while undergoing fMRI
The main questions it aims to answer are
1 Is the acutetransient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS rTMS
2 Do any of these effects predict negative affect symptoms such as depression and anxiety
Participants will
1 Complete several tests to assess their cognitive abilities and emotional states
2 Undergo several brain scans including resting-state fMRI structural MRI diffusion tensor imaging DTI and task fMRI
3 Have two different types of TMS sequences single-pulse and repetitive pulses administered to specific brain regions while undergoing fMRI
Detailed Description:
The purpose of this study is to examine the neural mechanisms underlying transcranial magnetic stimulation TMS using concurrent functional magnetic resonance imaging fMRI Research is conducted in both healthy controls HCs and patients with high negative affect symptoms such as depression and anxiety Participants will undergo two visits the first lasting about two hours and the second scheduled within one week of the first lasting about one hour Approximately half male and half female participants aged 18-65 will be recruited The aims are to examine 1 whether the acutetransient effect induced by single-pulse TMS is related to the long-term modulatory effect induced by rTMS and 2 whether any of these effects predict negative affect symptoms such as depression and anxiety
In the first visit participants will complete several tests to assess their cognitive abilities and emotional states specifically measuring depression and anxiety levels These tests will help explore the relationship between their cognitiveemotional states and brain activity during TMS-fMRI After the tests participants will undergo several brain scans to determine the best locations for TMS during the second visit and to measure the strength of connections between different brain regions During the second visit participants will undergo three parts of TMS-fMRI scanning The first part involves applying single-pulse TMS to the dorsolateral prefrontal cortex DLPFC and a control area the vertex while taking fMRI scans This helps elucidate how TMS affects deep brain regions related to mood disorders By comparing brain responses to TMS between healthy controls and patients researchers can gain important knowledge of whether the neural pathways between stimulated region and these subcortical brain regions are disrupted in patients The second part includes theta-burst stimulation TBS of TMS to the DLPFC which is a stimulation protocol approved by Food and Drug Administration FDA Finally in the third part single-pulse TMS is administered again after TBS to see if the TBS has changed the brains response Comparing the after-TBS single-pulse TMS-evoked brain responses with before-TBS responses would allow the investigators to track whether the TBS could change the disrupted neural pathways in patients Investigators will also examine how participants cognitiveemotional test results and brain connectivity relate to the TMS-evoked brain responses and the effects of TBS Any potential relationships found can provide insight into the underlying mechanisms of how individual differences in cognitiveemotional functioning and brain connectivity profile might influence or be influenced by brain stimulation which could ultimately inform personalized approaches to neuromodulation therapies
In the first visit participants will complete several tests to assess their cognitive abilities and emotional states specifically measuring depression and anxiety levels These tests will help explore the relationship between their cognitiveemotional states and brain activity during TMS-fMRI After the tests participants will undergo several brain scans to determine the best locations for TMS during the second visit and to measure the strength of connections between different brain regions During the second visit participants will undergo three parts of TMS-fMRI scanning The first part involves applying single-pulse TMS to the dorsolateral prefrontal cortex DLPFC and a control area the vertex while taking fMRI scans This helps elucidate how TMS affects deep brain regions related to mood disorders By comparing brain responses to TMS between healthy controls and patients researchers can gain important knowledge of whether the neural pathways between stimulated region and these subcortical brain regions are disrupted in patients The second part includes theta-burst stimulation TBS of TMS to the DLPFC which is a stimulation protocol approved by Food and Drug Administration FDA Finally in the third part single-pulse TMS is administered again after TBS to see if the TBS has changed the brains response Comparing the after-TBS single-pulse TMS-evoked brain responses with before-TBS responses would allow the investigators to track whether the TBS could change the disrupted neural pathways in patients Investigators will also examine how participants cognitiveemotional test results and brain connectivity relate to the TMS-evoked brain responses and the effects of TBS Any potential relationships found can provide insight into the underlying mechanisms of how individual differences in cognitiveemotional functioning and brain connectivity profile might influence or be influenced by brain stimulation which could ultimately inform personalized approaches to neuromodulation therapies
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