Healthy Volunteers OnlyNetworkTMSNCT06645613
TMS With Real-time E-field and EEG Source Imaging
A study testing Transcranial Magnetic Stimulation Device in people with Healthy Volunteers Only, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this study is to develop and validate an approach for accurate targeting and stimulation of brain networks using transcranial magnetic stimulation (TMS) using information from magnetic resonance imaging (MRI) data. This study requires two visits from each participant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- Transcranial Magnetic Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Sep 2029
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 65 years.
- Able to understand and give informed consent/assent.
- No prior neuropsychiatric, neurological disorders, epilepsy, or seizures.
- No metal implants.
- Absent of lesions or tumors from MRI scans.
Who cannot join
- The presence of a cardiac pacemaker or pacemaker wires.
- Metallic particles in the eye.
- Vascular clips in the head or previous neurosurgery.
- Prosthetic heart valves.
- Significant claustrophobia.
- Non-fixed metallic particles (shrapnel).
Show all 9Show fewer
- Any magnetic metallic particles in the body.
- Failure to assure non-pregnant status.
- Failure to perform the task of lying still.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH at the Navy Yard
Charlestown, Massachusetts, 02129
About this study
Official title: Precision TMS With Integrated Visualization and Analysis of Real-time E-field and EEG Source Imaging
The goal of this study is to develop and validate an approach for accurate targeting and stimulation of brain networks using transcranial magnetic stimulation (TMS) using information from magnetic resonance imaging (MRI) data. This study requires two visits from each participant.
In the first visit, the participant will be scanned by MRI scanners to collect data from the brain.
Read more
Next, the data will be analyzed by the researcher to model the connections between different regions of the brain to determine the stimulation areas related to the so-called frontoparietal network.
In the second visit, the participants will take four TMS sessions with different types of stimulations applied to the computed targets and complete a computer-based task named multi-source interference task. Electroencephalogram (EEG) data will be collected during the TMS stimulations and tasks.
The main hypothesis is that applying TMS stimulations to the brain targets reduces the response time and response error in the tasks.
Read the detailed description
The main goal of this study is to develop and validate an approach to target and stimulate brain networks using transcranial magnetic stimulation using information from magnetic resonance imaging (MRI).
Participants in this study will first be scanned using an MRI scanner to collect data from the brain. The MRI session will take about 40 minutes to acquire anatomical MRI, diffusion MRI, and resting-state functional MRI from the subjects.
Next, the researchers will analyze the MRI data to determine the stimulation areas of each participant. The method will provide two target areas in the brain, including an area in the left dorsolateral prefrontal cortex (DLPFC) and an area in the left inferior parietal lobule (IPL), which are involved in the frontoparietal network related to the executive control functions of the brain.
In the second visit, the participants will take TMS stimulations to the determined brain targets at DLPFC and IPL. The standard intermittent theta-burst (iTBS) protocol will be applied to the targets. To evaluate the effect of TMS stimulations, the participants will perform a computer-based task, named multi-source interference task (MSIT), before the TMS stimulation and another task after the TMS stimulations. The participants will click mouse buttons to respond to instructions in the tasks.
The response time and response error of the tasks will be the outcome measures of this study. The hypothesis is that applying TMS stimulations to the developed brain network targets reduces the response time and response error.
During the TMS stimulations and tasks, electroencephalogram (EEG) data will be collected from the participants. The EEG data, MRI data, and TMS-induced electric field maps will be analyzed and visualized using a software named SlicerTMS. However, the information shown in SlicerTMS will not be used to change the stimulation protocol in this study.
- Conditions
- Healthy Volunteers Only
- Being tested
- Transcranial Magnetic Stimulation Device
- Keywords
- transcranial magnetic stimulation, magnetic resonance imaging, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation DeviceDevice
Transcranial magnetic stimulation uses FDA-approved coils to generate varying magnetic fields in the brain of the participant and induce an electric field in the underlying brain tissue. The standard intermittent Theta Burst Stimulation (iTBS) TMS protocol will be applied in this study. The same coil can be applied to generate sham stimulations that only generate sound and stimulations to the scalp without stimulating the brain.
| Study group | Role | What they receive |
|---|---|---|
| Sham Transcranial Magnetic Stimulation | Sham comparator | Sham TMS coils will be applied to stimulate the brain targets. No magnetic field will be generated using the sham coil. It will play sounds similar to the true TMS stimulations with the pulsed weak electric current applied to the scalp to generate a similar feeling as in true stimulations. Receives: Device: Transcranial Magnetic Stimulation Device |
| Transcranial Magnetic Stimulation | Experimental | TMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants. Receives: Device: Transcranial Magnetic Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
choice reaction time (CRT)
CRT is the time that the participant takes to click the mouse button in the computer-based Multi-Source Interference Task.
Measured: 5 to 15 minutes right before and after each TMS session
Secondary outcomes (1)
response error
The rate of incorrect response in the MSIT task.
Measured: 5 to 15 minutes right before and after each TMS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Mar 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a sham-controlled cross-over study. The participants will take a random order of sham or real TMS stimulations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lipeng Ning, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645613
- Sponsor's protocol ID
- 2024P001808
- Acronym
- NetworkTMS
- Status last verified
- Jan 2026
- First submitted
- 11 Oct 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision TMS With Integrated Visualization and Analysis of Real-time E-field and EEG Source Imaging
- ClinicalTrials.gov ID
- NCT06645613
- Acronym / sponsor ID
- NetworkTMS / 2024P001808
- Conditions
- Healthy Volunteers Only
- Keywords
- transcranial magnetic stimulation, magnetic resonance imaging, EEG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 17 Oct 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.
The goal of this study is to develop and validate an approach for accurate targeting and stimulation of brain networks using transcranial magnetic stimulation (TMS) using information from magnetic resonance imaging (MRI) data. This study requires two visits from each participant.
In the first visit, the participant will be scanned by MRI scanners to collect data from the brain.
Next, the data will be analyzed by the researcher to model the connections between different regions of the brain to determine the stimulation areas related to the so-called frontoparietal network.
In the second visit, the participants will take four TMS sessions with different types of stimulations applied to the computed targets and complete a computer-based task named multi-source interference task. Electroencephalogram (EEG) data will be collected during the TMS stimulations and tasks.
The main hypothesis is that applying TMS stimulations to the brain targets reduces the response time and response error in the tasks.
Detailed description
The main goal of this study is to develop and validate an approach to target and stimulate brain networks using transcranial magnetic stimulation using information from magnetic resonance imaging (MRI).
Participants in this study will first be scanned using an MRI scanner to collect data from the brain. The MRI session will take about 40 minutes to acquire anatomical MRI, diffusion MRI, and resting-state functional MRI from the subjects.
Next, the researchers will analyze the MRI data to determine the stimulation areas of each participant. The method will provide two target areas in the brain, including an area in the left dorsolateral prefrontal cortex (DLPFC) and an area in the left inferior parietal lobule (IPL), which are involved in the frontoparietal network related to the executive control functions of the brain.
In the second visit, the participants will take TMS stimulations to the determined brain targets at DLPFC and IPL. The standard intermittent theta-burst (iTBS) protocol will be applied to the targets. To evaluate the effect of TMS stimulations, the participants will perform a computer-based task, named multi-source interference task (MSIT), before the TMS stimulation and another task after the TMS stimulations. The participants will click mouse buttons to respond to instructions in the tasks.
The response time and response error of the tasks will be the outcome measures of this study. The hypothesis is that applying TMS stimulations to the developed brain network targets reduces the response time and response error.
During the TMS stimulations and tasks, electroencephalogram (EEG) data will be collected from the participants. The EEG data, MRI data, and TMS-induced electric field maps will be analyzed and visualized using a software named SlicerTMS. However, the information shown in SlicerTMS will not be used to change the stimulation protocol in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a sham-controlled cross-over study. The participants will take a random order of sham or real TMS stimulations.
| Arm | Type | Receives |
|---|---|---|
| Sham Transcranial Magnetic Stimulation | Sham comparator | Device: Transcranial Magnetic Stimulation DeviceSham TMS coils will be applied to stimulate the brain targets. No magnetic field will be generated using the sham coil. It will play sounds similar to the true TMS stimulations with the pulsed weak electric current applied to the scalp to generate a similar feeling as in true stimulations. |
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic Stimulation DeviceTMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 and less than 65 years.
- Able to understand and give informed consent/assent.
- No prior neuropsychiatric, neurological disorders, epilepsy, or seizures.
- No metal implants.
- Absent of lesions or tumors from MRI scans.
Key exclusion criteria (9 listed)
- The presence of a cardiac pacemaker or pacemaker wires.
- Metallic particles in the eye.
- Vascular clips in the head or previous neurosurgery.
- Prosthetic heart valves.
- Significant claustrophobia.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation DeviceTranscranial magnetic stimulation uses FDA-approved coils to generate varying magnetic fields in the brain of the participant and induce an electric field in the underlying brain tissue. The standard intermittent Theta Burst Stimulation (iTBS) TMS protocol will be applied in this study. The same coil can be applied to generate sham stimulations that only generate sound and stimulations to the scalp without stimulating the brain. | Device | Sham Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation |
Primary outcome
choice reaction time (CRT)
Time frame: 5 to 15 minutes right before and after each TMS session
CRT is the time that the participant takes to click the mouse button in the computer-based Multi-Source Interference Task.
1 secondary outcome
response error
Time frame: 5 to 15 minutes right before and after each TMS session
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 27 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation Device in people with Healthy Volunteers Only, run by Brigham and Women's Hospital 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
choice reaction time (CRT) (time frame: 5 to 15 minutes right before and after each TMS session). 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 27 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.