Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) (NCT06868914) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
United States35 participantsStarted 2026-07-02
Plain-language 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....
Who can participate
Age range
22 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-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.
-Justification: Written informed consent must be obtained for this study per NIH policy and federal regulations.
Exclusion criteria
Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days or other neurological condition deemed by the MAI to be likely to affect response to the TBS being delivered.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase I trial testing high-density theta burst stimulation on healthy volunteers, what does it mean that there's no disease being treated here — and would participating offer me any personal medical benefit, or is this purely about gathering safety data?
2The trial is listed as 'not yet recruiting' — how would my doctor help me find out when enrollment opens, and is there a reason to wait or look at other options in the meantime?
3The main thing being measured is whether participants experience clinically significant adverse events from the brain stimulation — what kinds of side effects or risks has my doctor seen associated with noninvasive brain stimulation techniques like theta burst stimulation?
4Because this is a Phase I study focused on safety in healthy people, what does my doctor think about what 'healthy volunteer' means in practice — are there health conditions, medications, or personal history factors that would make me a poor fit or increase my risk?
5If I were to discuss this trial with my care team, what questions should I be asking about the monitoring process — specifically, how would any unexpected reactions during or after the stimulation sessions be caught and handled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
First-degree family history of any form of epilepsy with a potentially hereditary basis.
Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes TMS intervention.
Noise-induced hearing loss or tinnitus.
Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action.
Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.
Current use of nicotine (self-report, urine cotinine test and/ or CO consistent with smoker) or history of more than 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.
Current regular use of more than 2 cups of coffee or equivalent caffeine intake in the morning (not total daily intake).