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NCT06868914 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Not yet
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT06868914: Clinical Trial Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT06868914 is a Phase 1 study that has not yet begun recruiting, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06868914, a Phase 1 study, has not yet begun recruiting, sponsored by National Institute on Drug Abuse (NIDA).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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....
Primary Outcome
As a phase I trial, 25 participants are a reasonable sample size for a preliminary assessment of the safety profile of the hdTBS paradigm.
Interventions
- DEVICE TMS (MagVenture MagPro 100 with MagOption)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-01-13 |
| Phase | Phase 1 |
What is known before NCT06868914 opens enrollment
NCT06868914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which TMS (MagVenture MagPro 100 with MagOption) is the first listed.
NCT06868914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06868914 about?
NCT06868914 is a clinical study titled "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...
What is the current status of trial NCT06868914?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2026-07-15. Estimated completion is 2028-01-13.
What interventions are being tested in trial NCT06868914?
The interventions under investigation include: TMS (MagVenture MagPro 100 with MagOption) (DEVICE).
Who is sponsoring clinical trial NCT06868914?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06868914's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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