Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
Condition: Healthy Volunteer
Study type: Interventional

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.
    

Intervention name(s): TMS
Intervention type(s): Device
Intervention description(s): HAC coil (real rTMS or sham rTMS)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Within-subject design with each subject completing up to 10 rTMS sessions.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Repetitive TMS (rTMS); Parameter Development; Cognitive Tasks; MRI (Magnetic Resonance Imaging)