Healthy VolunteersNCT03394066
Mechanism of Non-invasive Magnetic Stimulation
A study testing TMS (MagVenture MagPro 100 with MagOption) in people with Healthy Volunteers, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TMS (MagVenture MagPro 100 with MagOption)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 31 Dec 2028
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be:
- 18 - 60 years of age.
- -Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.
- --Screening tool: History.
- In good health.
- Justification: Many illnesses may alter neural functioning as well as fMRI signals.
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- Screening tools: Vital Signs, height/weight measurements, Medical History, Physical Examination, and lab tests. Labs may include, but are not limited to: CBC, Hemoglobin A1C, CMP, ESR, and salivary HIV (blood may be tested for HIV if needed to confirm a positive salivary test). Elevated serum glucose may be followed up to assess for diabetes. MAI will assess if participants are generally healthy and will make the final judgment on any questionable lab results.
- Right-handed.
- Justification: Using right-handed individuals will reduce variability in BOLD MRI data.
- Screening tool: self-report.
Who cannot join
- 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.
- Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Neurological symptoms could potentially alter BOLD signal.
- Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.
- 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.
- Screening tool: TMS safety screening, Medical History.
Show all 42Show fewer
- 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 either MRI scanning or TMS intervention.
- Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.
- Screening tool: TMS safety screening, MRI safety screening, Medical History.
- Any contraindications to MRI or TMS.
- Justification: There are additional contraindications that would exclude participation in MRI or TMS (e.g., claustrophobia).
- Screening tool: MRI safety screening, TMS Safety Screening, and mock scanner trial (if deemed necessary).
- Noise-induced hearing loss or tinnitus.
- Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment.
- Screening tools: TMS safety screening.
- 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.
- Screening tools: MRI safety screening questionnaire and Medical history. A Urine toxicology that analyzes for presence of a broad range of prescription and nonprescription drugs may also be completed per the NIDA IRP screening protocol.
- 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 subjects with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. Psychiatric symptoms could potentially alter BOLD signal.
- Screening tools: a mental health screening questionnaire and /or a semi-structured or structured psychiatric interview such as the Structured Clinical Interview for the DSM (SCID) or clinician assessment. Potential diagnoses will be further evaluated by a mental health professional.
- Current use of nicotine or history more than about 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.
- Screening tools: Self-report and CO < 6. A commercial urine cotinine test may also be used, with the expectation that results correspond to non-smoker status for the specific test being used, typically corresponding to a urine cotinine under about 20 ng/ml.
- Meet current DSM-5 criteria for any substance use disorder, smoke daily, or urine toxicology positive for any illicit substance inconsistent with history given.
- Justification: The population of interest here 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.
- Screening tools: a drug use survey (DUS) and urine qualitative drug screen for common drugs of abuse. SUD may also be evaluated in a structured/semi-structured psychiatric interview such as the SCID and follow up with a mental health professional). Participants who test positive at screening (under the NIDA IRP screening protocol) may be assessed for current intoxication. For participants who are not found to be currently intoxicated, screening staff will assess for SUD and coherence of their drug use history and toxicology with particular attention to substances for which they are positive and may require a return screening visit to demonstrate ability to produce a negative urine before allowing them to proceed to clearance for this study.
- Have met DSM-5 criteria for any substance use disorder in the past.
- Justification: the population of interest here is a healthy control population with no present or past substance use disorder.
- Screening tools: a drug use survey (DUS) and/or a structured/semi-structured psychiatric interview such as the SCID and follow up with a mental health professional).
- Pregnant individuals or those with reproductive potential who are sexually active and not using an acceptable form of contraception.
- Justification: it is unknown whether TMS or MRI poses a risk to fetuses.
- Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI.
- Participation in a TMS session less than two weeks ago.
- Justification: in order to limit exposure to TMS, we will not enroll subjects who have received TMS less than two weeks ago.
- Screening tool: TMS safety screening questionnaire, and/or medical history.
- History of learning disability, current ADHD or cognitive impairment
- Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions and may introduce significant variably into the data.
- Screening tool: self-report of special education classes, history of specific learning disability or mental retardation, and medical history. A validated IQ test such as Wechsler Abbreviated Scale of Intelligence (WASI) or Shipley-2 may also be completed.
- Non-English Speaking
- Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS procedures. The inability to effectively communicate MRI and TMS safety procedures could compromise the safety of non-English speaking participants.
- Screening tool: self-report.
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
Kimberly Slater, B.A., 667-312-5287, kmodo@mail.nih.gov
About this study
Official title: Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation
Background:
Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.
Read more
Objectives:
To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.
Eligibility:
Healthy, right-handed adults ages 18-60 who are non-drug users.
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.
Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.
Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.
The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.
Read the detailed description
Objectives:
The goal of the protocol is to investigate acute modulations of brain activity by transcranial magnetic stimulation (TMS). Using simultaneous TMS and functional magnetic resonance imaging (fMRI), we will evaluate TMS induced changes in brain activity, including regional brain activation and inter-regional functional connectivity. Repetitive TMS will be applied over the dorsolateral prefrontal cortex (DLPFC) with different frequencies and interleaved with fMRI acquisition to provide online monitoring of brain activity. Furthermore, we will assess the relationship between the TMS induced brain activity and the anatomical connection obtained from diffusion tensor imaging (DTI), using individual variations in these imaging measures. Results from this study will help to understand the underling mechanism of TMS and will provide insights for interpretation of TMS and fMRI data.
Study population:
Up to 95 healthy, adults will be tested. Subjects must fit exclusion/inclusion criteria for both TMS and MRI. We expect to enroll 95 subjects to arrive at 50 who complete the protocol.
Design:
The study is a within-subject design with each subject completing up to 6 TMS-fMRI sessions in three days (2 sessions per day)
Outcome measures:
The outcome measures will be the effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
- Conditions
- Healthy Volunteers
- Being tested
- TMS (MagVenture MagPro 100 with MagOption)
- Keywords
- Repetitive TMS (rTMS), Simultaneous TMS and MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS (MagVenture MagPro 100 with MagOption)Device
TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-eight TMS coil. An MRI compatible version of the figure-of-eight coil will be used inside the MRI scanner with an appropriate TMS coil holder.
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | All participants will receive TMS to investigate acute modulations of brain activity by TMS Receives: Device: TMS (MagVenture MagPro 100 with MagOption) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI
Measured: TMS visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start19 Sep 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Yihong Yang, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394066
- Sponsor's protocol ID
- 999918042
- Other IDs
- 18-DA-N042
- Status last verified
- 23 Sep 2026
- First submitted
- 6 Jan 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caparelli EC, Schleyer B, Zhai T, Gu H, Abulseoud OA, Yang Y. High-Frequency Transcranial Magnetic Stimulation Combined With Functional Magnetic Resonance Imaging Reveals Distinct Activation Patterns Associated With Different Dorsolateral Prefrontal Cortex Stimulation Sites. Neuromodulation. 2022 Jun;25(4):633-643. doi: 10.1016/j.neurom.2022.03.002. Epub 2022 Apr 10.
PubMed 35418339
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT03394066
- Acronym / sponsor ID
- 999918042
- Conditions
- Healthy Volunteers
- Keywords
- Repetitive TMS (rTMS), Simultaneous TMS and MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jan 2018 (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:
Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.
Objectives:
To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.
Eligibility:
Healthy, right-handed adults ages 18-60 who are non-drug users.
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.
Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.
Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.
The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.
Detailed description
Objectives:
The goal of the protocol is to investigate acute modulations of brain activity by transcranial magnetic stimulation (TMS). Using simultaneous TMS and functional magnetic resonance imaging (fMRI), we will evaluate TMS induced changes in brain activity, including regional brain activation and inter-regional functional connectivity. Repetitive TMS will be applied over the dorsolateral prefrontal cortex (DLPFC) with different frequencies and interleaved with fMRI acquisition to provide online monitoring of brain activity. Furthermore, we will assess the relationship between the TMS induced brain activity and the anatomical connection obtained from diffusion tensor imaging (DTI), using individual variations in these imaging measures. Results from this study will help to understand the underling mechanism of TMS and will provide insights for interpretation of TMS and fMRI data.
Study population:
Up to 95 healthy, adults will be tested. Subjects must fit exclusion/inclusion criteria for both TMS and MRI. We expect to enroll 95 subjects to arrive at 50 who complete the protocol.
Design:
The study is a within-subject design with each subject completing up to 6 TMS-fMRI sessions in three days (2 sessions per day)
Outcome measures:
The outcome measures will be the effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: TMS (MagVenture MagPro 100 with MagOption)All participants will receive TMS to investigate acute modulations of brain activity by TMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 - 60 years of age.
- -Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.
- --Screening tool: History.
- In good health.
- Right-handed.
Key exclusion criteria (42 listed)
- 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.
- 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 either MRI scanning or TMS intervention.
- Any contraindications to MRI or TMS.
- 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 |
|---|---|---|
| TMS (MagVenture MagPro 100 with MagOption)TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-eight TMS coil. An MRI compatible version of the figure-of-eight coil will be used inside the MRI scanner with an appropriate TMS coil holder. | Device | TMS |
Primary outcome
effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
Time frame: TMS visits
fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI
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 8 Oct 2026.
- Derived from this study: PubMed 35418339Caparelli EC, Schleyer B, Zhai T, Gu H, Abulseoud OA, Yang Y. High-Frequency Transcranial Magnetic Stimulation Combined With Functional Magnetic Resonance Imaging Reveals Distinct Activation Patterns Associated With Different Dorsolateral Prefrontal Cortex Stimulation Sites. Neuromodulation. 2022 Jun;25(4):633-643. doi: 10.1016/j.neurom.2022.03.002. Epub 2022 Apr 10.
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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.
Yihong Yang, 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 study testing TMS (MagVenture MagPro 100 with MagOption) in people with Healthy Volunteers, 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 10 inclusion and 42 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 8 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.
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?
effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI. (time frame: TMS visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394066, which also lists 1 linked publication.
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 8 Oct 2026.