New brain zapping technique tested for safety in healthy volunteers
NCT ID NCT06868914
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 59 times
Summary
This early-stage study tests a new form of transcranial magnetic stimulation (TMS) called high-density theta burst stimulation (hdTBS) in 35 healthy adults aged 22 to 60. The goal is to check if hdTBS is safe and to compare its effects on the brain to standard TMS. Participants will receive both real and sham stimulation over several visits while researchers monitor side effects and brain activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcranial magnetic stimulation (TMS) using high-density theta burst stimulation (hdTBS)
- What this could lead to
- If successful, this could pave the way for testing hdTBS as a potential treatment for conditions like depression or addiction.
- What could go wrong
- This is an early Phase 1 safety study in only 35 healthy volunteers, so results may not apply to patients. The new stimulation method may not work better than existing TMS.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Be 22-60 years of age. --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. * Ability and willingness to provide written informed consent. --Justification: At NIH/NIDA, written informed consent must be obtained for this study per NIH policy and federal regulations. At pSites, written informed consent must be obtained per applicable local institutional policy and regulations and as described in the pSite addendum. * Generally in good health. * Justification: Many illnesses may alter neural functioning. These will be evaluated by the MAI and excluded as needed. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: -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. * Justification: Stroke or head trauma can lower the seizure threshold, and are therefore contra indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. -First-degree family history of any form of epilepsy with a potentially hereditary basis. * Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold. -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. * Justification: Any metal around the head is a contraindication for TMS, as it involves exposure to a relatively strong magnetic field. -Noise-induced hearing loss or tinnitus. * Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS equipment. -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. * Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS. -Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania. * Justification: The population of interest here is a healthy control population with no psychiatric disorders. In participants with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. -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. * Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required. -Current regular use of more than 2 cups of coffee or equivalent caffeine intake in the morning (not total daily intake). * Justification: Excessive caffeine use can reduce seizure threshold and could potentially increase risk of TMS-induced seizure. -Meet current DSM-5 criteria for any substance use disorder, or urine toxicology positive for any illicit substance inconsistent with history given. * Justification: The population of interest is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS. -Have met DSM-5 criteria for any substance use disorder in the past. * Justification: the population of interest is a healthy control population with no present or past substance use disorder. -History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care. * Justifications: the risk of TMS for individuals with a heart condition is unknown. -Pregnant individuals or individuals with reproductive potential who are sexually active and do not report using contraception. * Justification: it is unknown whether TMS poses a risk to fetuses. -Otherwise TMS incompatible or have participated in any noninvasive brain stimulation (NIBS) session in the past two weeks or a NIBS treatment course in the past 6 months. * Justification: in order to limit exposure to TMS, we will not enroll participants who have received TMS less than two weeks ago.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institute on Drug Abuse
Baltimore, Maryland, 21224, United States
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Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106, United States
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