Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
145 participants
INTERVENTIONAL
2025-10-23
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
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.
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.
Intracranial EEG (iEEG) Recording
Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.
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.
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.
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.
Intracranial EEG (iEEG) Recording
Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.
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.
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.
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.
EEG Recording
Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
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.
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.
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.
EEG Recording
Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
Interventions
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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.
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.
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.
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.
EEG Recording
Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
Intracranial EEG (iEEG) Recording
Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Stanford University
OTHER
Responsible Party
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Corey Keller
Associate Professor
Principal Investigators
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Corey J Keller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of Iowa
Iowa City, California, United States
Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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72673-1
Identifier Type: -
Identifier Source: org_study_id
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