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Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Sponsor: 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: This is a multi-site study conducted at the Biomedical Research Center, National Institute on Drug Abuse Intramural Research Program in Baltimore, Maryland and Olin Neuropsychiatry Research Center in Hartford, Connecticut. 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....
Official title: 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
Key Details
Gender
All
Age Range
22 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10-14
Completion Date
2028-01-13
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
TMS (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.
Locations (2)
Olin Neuropsychiatry Research Center
Hartford, Connecticut, United States
National Institute on Drug Abuse
Baltimore, Maryland, United States