Normal PhysiologyEarly Phase 1NCT06561828
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
A Early Phase 1 study testing continuous Theta Burst Stimulation (cTBS) and intermittent Theta Burst Stimulation (iTBS) in people with Normal Physiology, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Normal Physiology
- What is being tested?
- continuous Theta Burst Stimulation (cTBS) and intermittent Theta Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 2 Nov 2044
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 investigational 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.
Show all 15Show fewer
- Recent history (within past 12 months) of learning disability, major DSM-5 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Thorsten Kahnt, 667-312-5175, thorsten.kahnt@nih.gov
About this study
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.
Read more
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.
- Conditions
- Normal Physiology
- Being tested
- continuous Theta Burst Stimulation (cTBS), intermittent Theta Burst Stimulation (iTBS), sham Theta Burst Stimulation (sham TBS)
- Keywords
- TMS, Decision Making, fMRI, Learning, Behavioral Tasks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous Theta Burst Stimulation (cTBS)Device
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 (iTBS)Device
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).
sham Theta Burst Stimulation (sham TBS)Device
iTBS or cTBS delivered with placebo side of A/P coil.
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1 | Experimental | Healthy volunteers in experiment 1 Receives: Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS); Device: sham Theta Burst Stimulation (sham TBS) |
| Experiment 2 | Experimental | Healthy volunteers in experiment 2 Receives: Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS); Device: sham Theta Burst Stimulation (sham TBS) |
| Experiment 3 | Experimental | Healthy volunteers in experiment 3 Receives: Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS) |
| Experiment 4 | Experimental | Healthy volunteers in experiment 4 Receives: Device: continuous Theta Burst Stimulation (cTBS) |
| Experiment 5 | Experimental | Healthy volunteers in experiment 5 Receives: Device: continuous Theta Burst Stimulation (cTBS); Device: sham Theta Burst Stimulation (sham TBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Performance
Responses on behavioral tasks
Measured: after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start29 Oct 2026 (estimated)
- Primary completion1 Nov 2044 (estimated)
- Study completion2 Nov 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thorsten Kahnt, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561828
- Sponsor's protocol ID
- 10001932
- Other IDs
- 001932-DA
- Status last verified
- 30 Jul 2026
- First submitted
- 17 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
- ClinicalTrials.gov ID
- NCT06561828
- Acronym / sponsor ID
- 10001932
- Conditions
- Normal Physiology
- Keywords
- TMS, Decision Making, fMRI, Learning, Behavioral Tasks
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2044 (estimated)
- Study completion
- 2 Nov 2044 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experiment 1 | Experimental | Device: continuous Theta Burst Stimulation (cTBS), Device: intermittent Theta Burst Stimulation (iTBS), Device: sham Theta Burst Stimulation (sham TBS)Healthy volunteers in experiment 1 |
| Experiment 2 | Experimental | Device: continuous Theta Burst Stimulation (cTBS), Device: intermittent Theta Burst Stimulation (iTBS), Device: sham Theta Burst Stimulation (sham TBS)Healthy volunteers in experiment 2 |
| Experiment 3 | Experimental | Device: continuous Theta Burst Stimulation (cTBS), Device: intermittent Theta Burst Stimulation (iTBS)Healthy volunteers in experiment 3 |
| Experiment 4 | Experimental | Device: continuous Theta Burst Stimulation (cTBS)Healthy volunteers in experiment 4 |
| Experiment 5 | Experimental | Device: continuous Theta Burst Stimulation (cTBS), Device: sham Theta Burst Stimulation (sham TBS)Healthy volunteers in experiment 5 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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 investigational 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous 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). | Device | Experiment 1, Experiment 2, Experiment 3, Experiment 4, Experiment 5 |
| intermittent 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). | Device | Experiment 1, Experiment 2, Experiment 3 |
| sham Theta Burst Stimulation (sham TBS)iTBS or cTBS delivered with placebo side of A/P coil. | Device | Experiment 1, Experiment 2, Experiment 5 |
Primary outcome
Task Performance
Time frame: after each intervention
Responses on behavioral tasks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thorsten Kahnt, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing continuous Theta Burst Stimulation (cTBS) and intermittent Theta Burst Stimulation (iTBS) in people with Normal Physiology, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NIDA IRP Screening Team ((800) 535-8254, researchstudies@nida.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task Performance (time frame: after each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.