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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT06868914
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
22 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS (MagVenture MagPro 100 with MagOption) — DEVICE
    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.

Study Details

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....

Key Dates

Start date
Jun 16, 2026
Status verified
Feb 2026
Primary completion
Jan 13, 2028
Completion
Jan 13, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Active TBS (3- and 5-pulse TBS)
    Each participant will receive 2 active TBS (3- and 5-pulse TBS) and 1 sham TBS on 3 visits separated by at least 48 hours to minimize any potential accumulating effects from prior visits.
  • Sham Comparator: Sham TBS
    Each participant will receive 2 active TBS (3- and 5-pulse TBS) and 1 sham TBS on 3 visits separated by at least 48 hours to minimize any potential accumulating effects from prior visits.

Primary Outcome Measure

Clinically significant adverse events as collected on the Noninvasive Brain Stimulation (NIBS) monitoring questionnaire and evaluated by the MAI in combination with the serious adverse event reports. [ Time Frame: about 3-4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Drug AbuseBaltimoreMaryland21224
Yihong Yang, Ph.D.
[email protected]
667-312-5364

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By research site
National Institute on Drug Abuse· Baltimore, MD

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