Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study

Not Applicable

Completed

Conditions: Healthy Volunteer

Interventions: Device: TMS

Registration Number: NCT02231892

Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham TMS	TMS	Sham setting on coil
Real TMS	TMS	rTMS (frequency and intensity)

Primary Outcome Measures

Name	Time	Method
Behavioral Outcome Measure	3x per session in Behavioral phase (before TMS, immediately after TMS, and 1 hour after TMS), and 2x per session in MRI Phase (before TMS and immediately after TMS).	Behavioral effects of INTENSITY (Sham/100%MT/110%MT) and demand for cognitive control, DEMAND (High/Medium/Low), were planned to be quantified via correct response time (RT) and trial accuracy using R Project for Statistical Computing (package afex, function mixed (Singmannet al, 2015)). RT data were planned to be submitted to a linear mixed model with a random intercept per subject and fixed effects of INTENSITY and DEMAND. Accuracy data were planned to be submitted to a generalized linear mixed model with a binomial distribution and logit link function with a random intercept per subject and fixed effects of INTENSITY and DEMAND. During the Behavioral phase of the study, this data was collected before TMS, immediately after TMS, and 1 hour after TMS. During the MRI phase of the study, this data was only collected before TMS and immediately after TMS.
Imaging Outcome Measures	Twice per session in MRI Phase (pre-TMS and immediately post-TMS)	These measures include resting state (seed-based functional connectivity), Arterial Spin labeling (ASL), and MRI Spectroscopy (MRS). 1. Seed based - correlation coefficient changes 2. ASL - % change 3. MRS - % change