Ignite Creation Date:
2024-05-06 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03394066
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2018-01-06
Brief Title:
Mechanism of Non-invasive Magnetic Stimulation
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation
Status:
RECRUITING
Status Verified Date:
2024-06-07
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:
Background
Transcranial magnetic stimulation TMS is form of non-invasive brain stimulation It is approved to treat depression TMS may help decrease drug craving It is important to understand how TMS affects the brain Such a better understanding would help to design ways to treat drug addiction
Objectives
To learn how TMS affects the brain when it stimulates an area in the front of the brain Also to see how the stimulation affects the area stimulated and other connected areas
Eligibility
Healthy right-handed adults ages 18 60 who are non-drug users
Design
Participants will be screened under protocol 06-DA-N415
Participants will have at least 3 visits The first visit will last about 3 hours All other visits will last up to 6 hours Participants cannot use drugs or alcohol at least 24 hours before a visit They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit
Each visit will include a brief medical history update urine test for drugs and pregnancy if female a breath test for alcohol and smoking and questionnaires
Participants will have a TMS orientation visit A wire coil will be placed on the head An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain
The other visits will include 2 sessions of TMS-MRI Participants will lie on a table that slides into a cylinder The TMS coil and the MRI coil will be placed over the head Pictures will be taken of the brain with and without stimulation
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 2 3 weeks after their last session
Transcranial magnetic stimulation TMS is form of non-invasive brain stimulation It is approved to treat depression TMS may help decrease drug craving It is important to understand how TMS affects the brain Such a better understanding would help to design ways to treat drug addiction
Objectives
To learn how TMS affects the brain when it stimulates an area in the front of the brain Also to see how the stimulation affects the area stimulated and other connected areas
Eligibility
Healthy right-handed adults ages 18 60 who are non-drug users
Design
Participants will be screened under protocol 06-DA-N415
Participants will have at least 3 visits The first visit will last about 3 hours All other visits will last up to 6 hours Participants cannot use drugs or alcohol at least 24 hours before a visit They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit
Each visit will include a brief medical history update urine test for drugs and pregnancy if female a breath test for alcohol and smoking and questionnaires
Participants will have a TMS orientation visit A wire coil will be placed on the head An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain
The other visits will include 2 sessions of TMS-MRI Participants will lie on a table that slides into a cylinder The TMS coil and the MRI coil will be placed over the head Pictures will be taken of the brain with and without stimulation
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 2 3 weeks after their last session
Detailed Description:
Objectives
The goal of the protocol is to investigate acute modulations of brain activity by transcranial magnetic stimulation TMS Using simultaneous TMS and functional magnetic resonance imaging fMRI we will evaluate TMS induced changes in brain activity including regional brain activation and inter-regional functional connectivity Repetitive TMS will be applied over the dorsolateral prefrontal cortex DLPFC with different frequencies and interleaved with fMRI acquisition to provide online monitoring of brain activity Furthermore we will assess the relationship between the TMS induced brain activity and the anatomical connection obtained from diffusion tensor imaging DTI using individual variations in these imaging measures Results from this study will help to understand the underling mechanism of TMS and will provide insights for interpretation of TMS and fMRI data
Study population
Up to 70 healthy adults will be tested Subjects must fit exclusioninclusion criteria for both TMS and MRI We expect to enroll 70 subjects to arrive at 50 who complete the protocol
Design
The study is a within-subject design with each subject completing up to 6 TMS-fMRI sessions in three days 2 sessions per day
Outcome measures
The outcome measures will be the effects of TMS on fMRI blood oxygen level-dependent BOLD responses TMS induced changes on resting state functional connectivity and their associations with relevant structural connectivity revealed by DTI
The goal of the protocol is to investigate acute modulations of brain activity by transcranial magnetic stimulation TMS Using simultaneous TMS and functional magnetic resonance imaging fMRI we will evaluate TMS induced changes in brain activity including regional brain activation and inter-regional functional connectivity Repetitive TMS will be applied over the dorsolateral prefrontal cortex DLPFC with different frequencies and interleaved with fMRI acquisition to provide online monitoring of brain activity Furthermore we will assess the relationship between the TMS induced brain activity and the anatomical connection obtained from diffusion tensor imaging DTI using individual variations in these imaging measures Results from this study will help to understand the underling mechanism of TMS and will provide insights for interpretation of TMS and fMRI data
Study population
Up to 70 healthy adults will be tested Subjects must fit exclusioninclusion criteria for both TMS and MRI We expect to enroll 70 subjects to arrive at 50 who complete the protocol
Design
The study is a within-subject design with each subject completing up to 6 TMS-fMRI sessions in three days 2 sessions per day
Outcome measures
The outcome measures will be the effects of TMS on fMRI blood oxygen level-dependent BOLD responses TMS induced changes on resting state functional connectivity and their associations with relevant structural connectivity revealed by DTI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-DA-N042 | None | None | None |