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NCT Number: NCT07242105

Optimizing Brain Excitability in Depression

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).

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women, ages 18 to 65
  • Diagnosis of major depressive disorder, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)
  • In a current depressive episode, assessed through a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
  • Moderate-to-severe depression as indicated by a score between 11-20 on the Quick Inventory of Depressive Symptoms (QIDS)
  • Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
  • No current or history of neurological disorders
  • No seizure disorder or risk of seizures
  • Neurosurgical patients: Men and women ages 18-65 with medication-refractory epilepsy who are admitted for phase II intracranial monitoring to detect a seizure focus will be considered appropriate for this study. Participants must have the intellectual capacity to understand the consent process and agree to the study.

Exclusion criteria

  • Those with a contraindication for MRIs (e.g. implanted metal)
  • History of head trauma with loss of consciousness
  • History of seizures or on medications that reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
  • Neurological or uncontrolled medical disease
  • Any unstable medical condition
  • Active substance abuse
  • Diagnosis of psychotic or bipolar disorder
  • A prior history of Electroconvulsive Therapy (ECT) failure
  • History of suicide attempt in the past year
  • Currently pregnant or breastfeeding
  • Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past six months

Treatment and study plan

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.

Primary outcomes

  1. Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS)

    Time frame: Baseline, end of spTMS (6 hours)

    Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the anterior dlPFC.

  2. Changes in Posterior EL-TEP Amplitude after spTMS

    Time frame: Baseline, end of spTMS (6 hours)

    Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the posterior dlPFC.

  3. Changes in intracranial TMS-Evoked Potential (iTEP) Amplitude after TMS-iEEG

    Time frame: Baseline, end of spTMS (20 minutes)

    Changes in the interaction between gyral/sulcal targets and coil angles (45 vs 90 degrees) on local dlPFC iTEP amplitude.

Study contacts

Contact information is provided by the study sponsor or research team.

Jade T Truong, BS

CONTACT

[email protected]

408-840-3313

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimized Methods for Measuring Brain Excitability in Depression

Acronym: TARGET

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 21, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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