Phase I Clinical Trial to Study the Safety and After-effects of Transcranial Magnetic Stimulation (TMS) Using A High-density Theta Burst Stimulation (hdTBS) Paradigm
National Institute on Drug Abuse (NIDA)
Summary
Background: Transcranial magnetic stimulation (TMS) uses magnetic pulses to affect brain activity. A type of TMS called theta burst stimulation (TBS) is approved to treat people with major depression. Researchers have developed a new form of TBS called high-density TBS (hdTBS). They hope hdTBS will work better than TBS. But first they need to test the new treatment in healthy adults. Objective: To test hdTBS in healthy adults. Also, to compare the aftereffects of hdTBS and TBS. Eligibility: Healthy adults aged 22 to 60 years. Design: Participants will have 4 clinic visits over about 3 to 4 weeks. They must abstain from drugs and alcohol and limit caffeine before visits. At their first visit, participants will be oriented to TBS. They will wear a cap and earplugs. A device with round coils will be placed near their head. When a brief electric current passes through the coil, it generates a magnetic pulse that stimulates the brain. Participants may feel a pulling sensation on the skin under the coil. Their fingers may move involuntarily. At their next 3 visits, participants will receive either TBS or sham TBS. A sham TBS uses a low magnetic field to minimize the effects of the treatment. Participants will have up to 9 electrodes placed on 1 arm. These electrodes will measure the electrical activity in their muscles. Each TBS session will be videotaped. At every visit, participants will answer questions about their health, including substance use. They will perform 2 tasks to test their thinking skills. They will perform a test on a computer to test their reaction time....
Description
Study Description: This study is intended to test the safety and potential efficacy of the highdensity theta burst stimulation (hdTBS) paradigm. We hypothesize that hdTBS i) can be safely administered to normal healthy human subjects, and ii) can produce stronger and longer-lasting after-effects than the conventional FDA-approved TBS paradigm. Objectives: Primary Objective: To determine whether hdTBS at the power level of 60% and 80% resting motor threshold can be safely administered to normal healthy human participants. Secondary Objective: To determine whether hdTBS produces stronger a…
Eligibility
- Age range
- 22–60 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Be 22-60 years of age. --Justification: Many neural processes change with age, and these changes could introduce unwanted variability in behavior. In addition, the risk of difficult-to detect medical abnormalities such as silent cerebral infarcts increase with age. Children under the age of 22 are excluded from this study because safety of rTMS in children has not been studied. In addition, this study is more than minimal risk and presents no direct benefit.…
Interventions
- DeviceTMS (MagVenture MagPro 100 with MagOption)
TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-8 TMS coil. Each subject will receive 2 active TBS (3- and 5-pulse TBS) and 1 sham TBS on 3 visits separated by at least 48 hours.
Location
- National Institute on Drug AbuseBaltimore, Maryland