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Recruiting NCT07242105

Optimizing Brain Excitability in Depression

No phase Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Single-Pulse TMS, Sham Single-Pulse TMS, TARGET-optimized TMS, Non-optimized (Open-Loop) TMS.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimized Methods for Measuring Brain Excitability in Depression

Overview

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).

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.

Primary outcome measures

  • Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS) [Time frame: Baseline, end of spTMS (6 hours)]
  • Changes in Posterior EL-TEP Amplitude after spTMS [Time frame: Baseline, end of spTMS (6 hours)]
  • Changes in intracranial TMS-Evoked Potential (iTEP) Amplitude after TMS-iEEG [Time frame: Baseline, end of spTMS (20 minutes)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of Iowa — Iowa City
  • Stanford University — Stanford

Identifiers

NCT: NCT07242105 · 72673-1 · 1R01MH139650

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗