Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-03-01
2029-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Repetitive Transcranial Magnetic Stimulation on Brain Activity in Healthy Human Volunteers
NCT01369264
Effects of Transcranial Magnetic Stimulation (TMS) on Somatosensory Perception
NCT02119637
Task-dependent Effects of TMS on the Neural Biomarkers of Episodic Memory
NCT04694131
Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
NCT06376734
TMS - Intracranial Electrodes
NCT03702127
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sham Transcranial Magnetic Stimulation
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.
Transcranial Magnetic Stimulation Device
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.
Transcranial Magnetic Stimulation
TMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants.
Transcranial Magnetic Stimulation Device
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcranial Magnetic Stimulation Device
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to understand and give informed consent/assent.
3. No prior neuropsychiatric, neurological disorders, epilepsy, or seizures.
4. No metal implants.
5. Absent of lesions or tumors from MRI scans.
Exclusion Criteria
2. Metallic particles in the eye.
3. Vascular clips in the head or previous neurosurgery.
4. Prosthetic heart valves.
5. Significant claustrophobia.
6. Non-fixed metallic particles (shrapnel).
7. Any magnetic metallic particles in the body.
8. Failure to assure non-pregnant status.
9. Failure to perform the task of lying still.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
National Institute of Mental Health (NIMH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lipeng Ning, PhD
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MGH at the Navy Yard
Charlestown, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024P001808
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.