An Early Phase 1 interventional study of continuous Theta Burst Stimulation (cTBS) and intermittent Theta Burst Stimulation (iTBS) in Normal Physiology, sponsored by National Institute on Drug Abuse (NIDA). Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Institute on Drug Abuse (NIDA) · Early Phase 1, Interventional, and Basic science
Background:
People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to know how a technique called transcranial magnetic stimulation (TMS) may cause changes in brain activity that may help people with SUD.
Objective:
To test TMS in healthy volunteers.
Eligibility:
Healthy people aged 18 to 45 years who are right-handed.
Design:
Participants can volunteer for up to 5 different experiments. Each experiment requires 2 to 8 clinic visits. Each visit will last 3 to 7 hours.
Some visits will include TMS. A coil will be placed on the participant s head. A brief electrical current will pass through the coil to create a magnetic field. Participants may feel a tapping or pulling sensation on the skin under the coil. They may feel a twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense certain muscles during TMS.
Some visits will include functional magnetic resonance imaging (fMRI) scans. Participants will lie on a bed that slides into a large tube. They will perform tasks on a computer inside the tube. The fMRI will show which parts of the brain are used during each task.
Participants will perform tasks on a computer. Some tasks may be done at a desk as well as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors, or taste flavored liquids. Their vital signs may be monitored and their eye movements may be tracked during tasks.
Study Description:
Learning and decision-making are critical for adaptive behavior and survival. Treating maladaptive behaviors in neuropsychiatric conditions, such substance use disorder, requires knowledge about the causal neural mechanisms supporting these functions as well as ways to modulate them. The goal of the current study is to develop and validate neuromodulation protocols that target specific cognitive functions involved in learning and decision making.
Objectives:
The primary objective is to develop and validate non-invasive neuromodulation protocols that target specific cognitive functions related to learning and decision making and modulate activity in associated brain networks.
Endpoints:
The primary endpoints are to determine if the developed neuromodulation protocols reliably modulate specific cognitive functions and whether they modulate activity in the targeted brain networks.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet the following criteria:
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria will be excluded from participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers in experiment 1
Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS) · Device: sham Theta Burst Stimulation (sham TBS)
Healthy volunteers in experiment 2
Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS) · Device: sham Theta Burst Stimulation (sham TBS)
Healthy volunteers in experiment 3
Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS)
Healthy volunteers in experiment 4
Device: continuous Theta Burst Stimulation (cTBS)
Healthy volunteers in experiment 5
Device: continuous Theta Burst Stimulation (cTBS) · Device: sham Theta Burst Stimulation (sham TBS)
Continuous theta burst stimulation (three TMS pulses delivered at 50Hz with the bursts delivered at 5Hz for a total of 600 pulses per site).
Intermittent theta burst stimulation (three TMS pulses delivered at 50Hz with the bursts delivered at 5Hz for 2 seconds followed by a break of 8 seconds for a total of 600 pulses per site).
iTBS or cTBS delivered with placebo side of A/P coil.
Task Performance
Responses on behavioral tasks
Time frame: after each intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2044, 215 months later.
Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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