Optimizing Brain Excitability in Depression

Part of paid clinical trials in Iowa City, California.

Sponsor
Stanford University
Study ID
NCT07242105
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Active Single-Pulse TMS — DEVICE
    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.
  • Sham Single-Pulse TMS — DEVICE
    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.
  • TARGET-optimized TMS — DEVICE
    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.
  • Non-optimized (Open-Loop) TMS — DEVICE
    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.
  • EEG Recording — OTHER
    Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
  • Intracranial EEG (iEEG) Recording — OTHER
    Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.

Study Details

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).

Key Dates

Start date
Oct 23, 2025
Status verified
Feb 2026
Primary completion
Aug 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active TMS, Sham TMS with iEEG
    Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.
  • Experimental: Sham TMS, Active TMS with iEEG
    Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.
  • Experimental: Optimized TMS, Non-optimized TMS with EEG
    Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.
  • Experimental: Non-optimized TMS, Optimized TMS with EEG
    Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.

Primary Outcome Measure

Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS) [ Time Frame: Baseline, end of spTMS (6 hours) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityCalifornia52246
Jade T Truong, BS
408-840-3313
Aaron D Boes, MD, PhD (SUB_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Jade T Truong, BS
408-840-3313
Corey J Keller, MD, PhD (PRINCIPAL_INVESTIGATOR)

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