ClinicalTrials.gg
RecruitingNCT06561828Updated Nov 10, 2026

Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

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

Updated Nov 10, 2026Start date movedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Normal Physiology

Keywords

  • TMS
  • Decision Making
  • fMRI
  • Learning
  • Behavioral Tasks
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet the following criteria:

  • Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.
  • In good general health based on the assessment of the MAI.
  • Right-handed.

Exclusion criteria

EXCLUSION CRITERIA:

Individuals who meet any of the following criteria will be excluded from participation:

  • Any neurological disorder that would increase seizure risk from TMS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.
  • Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).
  • Current use (any use in the past two weeks, daily use for more than one week within past 3 months) of any drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), anti or pro-convulsive action. This will be determined at the discretion of the MAI.
  • Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.
  • History of noise-induced hearing loss or tinnitus.
  • Recent history (within past 12 months) of learning disability, major psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.
  • Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
  • Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.
  • Participation in any neuromodulation (e.g., TMS, tFUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.
  • For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the protocol itself.
  • Uncorrected impairments in visual acuity severe enough to affect task participation.
  • Non-English speaking. Justification: Data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TMS and MRI procedures. The inability to effectively communicate TMS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
  • Pregnancy. Justification: It is unknown whether MRI and TMS pose risks to fetuses.
  • Any other condition that in the judgment of the investigators is incompatible with participation.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Experiment 1

    Healthy volunteers in experiment 1

    Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS) · Device: sham Theta Burst Stimulation (sham TBS)

  • Experimental
    Experiment 2

    Healthy volunteers in experiment 2

    Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS) · Device: sham Theta Burst Stimulation (sham TBS)

  • Experimental
    Experiment 3

    Healthy volunteers in experiment 3

    Device: continuous Theta Burst Stimulation (cTBS) · Device: intermittent Theta Burst Stimulation (iTBS)

  • Experimental
    Experiment 4

    Healthy volunteers in experiment 4

    Device: continuous Theta Burst Stimulation (cTBS)

  • Experimental
    Experiment 5

    Healthy volunteers in experiment 5

    Device: continuous Theta Burst Stimulation (cTBS) · Device: sham Theta Burst Stimulation (sham TBS)

Interventions

  • Devicecontinuous Theta Burst Stimulation (cTBS)

    Continuous theta burst stimulation (three TMS pulses delivered at 50Hz with the bursts delivered at 5Hz for a total of 600 pulses per site).

  • Deviceintermittent Theta Burst Stimulation (iTBS)

    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).

  • Devicesham Theta Burst Stimulation (sham TBS)

    iTBS or cTBS delivered with placebo side of A/P coil.

06

What researchers measure

Primary outcomes

  1. Task Performance

    Responses on behavioral tasks

    Time frame: after each intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

32 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

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.

Registered
Aug 17, 2024
First posted
Aug 20, 2024
StartEst.
Nov 15, 2026was Sep 2026
Primary completionEst.
Nov 1, 2044
CompletionEst.
Nov 2, 2044
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
    + 1 other change: verification date
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

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 ↗

10

Registry details

Key details

Study ID
NCT06561828
Responsible party
Sponsor
First posted
Aug 20, 2024
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 1, 2044 (estimated)
Completion
Nov 2, 2044 (estimated)
Last update
Nov 10, 2026

Study contacts

NIDA IRP Screening Team
Contact
researchstudies@nida.nih.gov
(800) 535-8254
Thorsten Kahnt, Ph.D.
Contact
thorsten.kahnt@nih.gov
(667) 312-5175
Thorsten Kahnt, Ph.D.
principal investigator · National Institute on Drug Abuse (NIDA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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