Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)

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....

NCT Number	NCT06868914
Lead Sponsor	National Institute on Drug Abuse (NIDA)
Conditions	Healthy Volunteers
Enrollment	35 participants
Start Date	2026-08-19
Primary Completion	2028-01-13 (estimated)
Study Completion	2028-01-13 (estimated)
Updated on ClinicalTrials.gov	2026-08-14