TMS With Real-time E-field and EEG Source Imaging

NCT06645613 | Active Not Recruiting FDA Device

• 1 other identifier: 2024P001808
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers Only

Keywords

transcranial magnetic stimulation; magnetic resonance imaging; EEG

Outcome Measures

Primary Outcomes (1)

• 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.

  5 to 15 minutes right before and after each TMS session

Secondary Outcomes (1)

• response error

  5 to 15 minutes right before and after each TMS session

Study Arms (2)

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.

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.

Device: Transcranial Magnetic Stimulation Device

Interventions

Transcranial Magnetic Stimulation Device 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.

Sham Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Any magnetic metallic particles in the body.
• Failure to assure non-pregnant status.
• Failure to perform the task of lying still.

Sponsors & Collaborators

• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

MGH at the Navy Yard

Charlestown, Massachusetts, 02129, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A random order of sham and real stimulations will be applied to the participants. A sham TMS coil will be used in the sham stimulations to generate the same sound as the real TMS coil. Moreover, a pulsed electric current will be applied to the scalp of the participants, which generates a feeling similar to that of real stimulations. In this way, the participants will be blind to the stimulation status.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a sham-controlled cross-over study. The participants will take a random order of sham or real TMS stimulations.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)