Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-27 @ 7:53 AM
Study NCT ID:
NCT03394066
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2018-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanism of Non-invasive Magnetic Stimulation
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation
Status:
RECRUITING
Status Verified Date:
2025-12-18
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 exclusion/inclusion 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 exclusion/inclusion 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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-DA-N042 | None | None | View |