Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02231892
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-09-18
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:
\- Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help people quit drugs. Researchers want to study how it works in healthy people first.
Objective:
\- To learn how to use rTMS to stimulate a brain area and to see how it affects brain function and thinking.
Eligibility:
\- Healthy, right-handed adults ages 18-55.
Design:
* Participants will be screened under another protocol.
* They will have 4-11 study visits.
* To start each visit, participants will have:
* Physical exam.
* Urine sample.
* Breath tests for alcohol and cigarette smoke.
* Questions about drug use and medications.
* Visit 1: participants will have:
* Single TMS pulses on the head to determine the right strength. They will wear earplugs and a cap. A wire coil will be placed on the head and an electrical current will go through it. Participants may perform simple muscle movements. They will repeat the procedures wearing another coil, in a helmet.
* A few TMS pulses to show how rTMS feels.
* A practice thinking task, maybe in a scanner that looks and sounds like a magnetic resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The participant will lie on a table that slides in and out of the cylinder.
* They may have a real MRI scan.
* Visits 2-11, participants will:
* Complete two questionnaires.
* Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored.
* Have their vital signs checked.
* They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner. They may just lie still in the MRI scanner.
\- Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help people quit drugs. Researchers want to study how it works in healthy people first.
Objective:
\- To learn how to use rTMS to stimulate a brain area and to see how it affects brain function and thinking.
Eligibility:
\- Healthy, right-handed adults ages 18-55.
Design:
* Participants will be screened under another protocol.
* They will have 4-11 study visits.
* To start each visit, participants will have:
* Physical exam.
* Urine sample.
* Breath tests for alcohol and cigarette smoke.
* Questions about drug use and medications.
* Visit 1: participants will have:
* Single TMS pulses on the head to determine the right strength. They will wear earplugs and a cap. A wire coil will be placed on the head and an electrical current will go through it. Participants may perform simple muscle movements. They will repeat the procedures wearing another coil, in a helmet.
* A few TMS pulses to show how rTMS feels.
* A practice thinking task, maybe in a scanner that looks and sounds like a magnetic resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The participant will lie on a table that slides in and out of the cylinder.
* They may have a real MRI scan.
* Visits 2-11, participants will:
* Complete two questionnaires.
* Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored.
* Have their vital signs checked.
* They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner. They may just lie still in the MRI scanner.
Detailed Description:
Objective: To establish an effective repetitive transcranial magnetic stimulation (rTMS) protocol for stimulating circuits relevant for addiction. Specifically, we will develop stimulation parameters and outcome measures for rTMS of the anterior cingulate cortex (ACC) with a specialized TMS coil: the HAC coil (Brainsway Ltd.). Various parameters of rTMS stimulation (frequency and intensity) will be varied, and the sensitivity of behavioral tasks and MRI measures to this stimulation will be determined. The objective of this protocol is therefore to allow for the development, assessment and refinement of rTMS parameters for stimulating ACC targets. In addition, outcome measures will be developed to capture the effects of this stimulation. Results from this development protocol will be applied to subsequent cognitive imaging protocols.
Study population: Up to 50 healthy, non-smoking adults will be tested in several conditions over up to two weeks. Subjects must fit exclusion/inclusion criteria for TMS and MRI. We expect 140 subjects to be enrolled to arrive at a number of 50 who complete the protocol.
Design: Within-subject design with each subject completing up to 10 rTMS sessions.
Outcome measures: In a first phase, the outcome measure will be the behavioral response on a task that relies on the ACC. In a second phase, outcome measures will be the effects on MR measures. These will include task-related blood oxygen level-dependent (BOLD) responses, as well as resting state BOLD functional magnetic resonance imaging (fMRI). Other MR measures, such as magnetic resonance spectroscopy (MRS) and arterial spin labeling (ASL), will also be explored as potential biomarkers.
Study population: Up to 50 healthy, non-smoking adults will be tested in several conditions over up to two weeks. Subjects must fit exclusion/inclusion criteria for TMS and MRI. We expect 140 subjects to be enrolled to arrive at a number of 50 who complete the protocol.
Design: Within-subject design with each subject completing up to 10 rTMS sessions.
Outcome measures: In a first phase, the outcome measure will be the behavioral response on a task that relies on the ACC. In a second phase, outcome measures will be the effects on MR measures. These will include task-related blood oxygen level-dependent (BOLD) responses, as well as resting state BOLD functional magnetic resonance imaging (fMRI). Other MR measures, such as magnetic resonance spectroscopy (MRS) and arterial spin labeling (ASL), will also be explored as potential biomarkers.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 14-DA-N186 | OTHER | NIDA | View |