Optimizing Brain Excitability in Depression

Summary

The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).

Conditions

• Major Depressive Disorder

Interventions

DEVICE

Active Single-Pulse TMS

Single-pulse transcranial magnetic stimulation is delivered to the left dorsolateral prefrontal cortex using a MagVenture X100 stimulator and B65 A/P coil across predefined locations, coil angles, and stimulation intensities.

DEVICE

Sham Single-Pulse TMS

Sham single-pulse TMS is delivered using a flipped coil and concurrent scalp electrical stimulation to mimic auditory and somatosensory sensations without producing cortical stimulation.

DEVICE

TARGET-optimized TMS

Single-pulse TMS parameters (location, angle, and intensity) are adjusted in real time using the TARGET closed-loop algorithm based on concurrent EEG measurements to deliver optimized stimulation.

DEVICE

Non-optimized (Open-Loop) TMS

Single-pulse TMS is delivered using a predefined open-loop set of stimulation parameter combinations across multiple dlPFC locations, coil angles, and intensities without real-time adjustment.

OTHER

EEG Recording

Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.

OTHER

Intracranial EEG (iEEG) Recording

Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Stanford University

  lead OTHER

Principal Investigators

• Corey J Keller, MD, PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-23

Primary Completion

2029-08-30

Completion

2029-11-30

FDA Device

Yes

Countries

• United States

Study Locations