ClinicalTrials.Veeva

Menu

TMS With Real-time E-field and EEG Source Imaging (NetworkTMS)

Mass General Brigham logo

Mass General Brigham

Status

Begins enrollment this month

Conditions

Healthy Volunteers Only

Treatments

Device: Transcranial Magnetic Stimulation Device

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06645613
2024P001808

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age greater than 18 and less than 65 years.
  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

  1. The presence of a cardiac pacemaker or pacemaker wires.
  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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

50 participants in 2 patient groups

Sham Transcranial Magnetic Stimulation
Sham Comparator group
Description:
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.
Treatment:
Device: Transcranial Magnetic Stimulation Device
Transcranial Magnetic Stimulation
Experimental group
Description:
TMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants.
Treatment:
Device: Transcranial Magnetic Stimulation Device

Trial contacts and locations

1

Loading...

Central trial contact

Lipeng Ning, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems