Major Depressive Disorder
Conditions
Keywords
tms, eeg
Brief 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).
Interventions
DEVICEActive 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.
DEVICESham 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.
DEVICETARGET-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.
DEVICENon-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.
OTHEREEG Recording
Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
OTHERIntracranial EEG (iEEG) Recording
Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.
Sponsors
Stanford University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS) | 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. |
| Changes in Posterior EL-TEP Amplitude after spTMS | 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. |
| Changes in intracranial TMS-Evoked Potential (iTEP) Amplitude after TMS-iEEG | 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. |
Countries
United States
Contacts
CONTACTJade T Truong, BS
PRINCIPAL_INVESTIGATORCorey J Keller, MD, PhD
Stanford University
Outcome results
None listed