Optimizing prefrontal excitability to improve depression treatment
Optimized Methods for Measuring Brain Excitability in Depression
This project will try EEG‑guided TMS using a real‑time TARGET algorithm to see if targeted stimulation helps adults 18–65 with moderate‑to‑severe major depressive disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Iowa City, California and 1 other locations) |
| Trial ID | NCT07242105 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses EEG-recorded prefrontal excitability markers and a real‑time algorithm called TARGET to guide single‑pulse TMS. Participants undergo active and sham single‑pulse TMS as well as TARGET‑optimized and non‑optimized (open‑loop) TMS while EEG is recorded to compare evoked potentials. Some neurosurgical patients admitted for intracranial monitoring may be included to validate cortical excitability measures directly. The aim is to establish reliable prefrontal excitability markers that could be used to personalize stimulation parameters.
Who should consider this trial
Good fit: Adults 18–65 with a current moderate‑to‑severe major depressive episode (QIDS score 11–20), who can understand English and have no history of seizures or other neurological disorders, are ideal candidates.
Not a fit: People with a history of seizures or other neurological disorders, those outside the 18–65 age range, non‑English speakers who cannot follow EEG/TMS instructions, or those with depression severity outside the specified range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could enable more personalized TMS by using EEG markers to improve response rates and speed recovery in people with depression.
How similar studies have performed: Standard TMS is an established treatment for depression and prior research shows promise for EEG‑guided targeting, but real‑time TARGET‑guided TMS is a novel approach that has not yet been proven in large clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, California and 1 other locations
- University of Iowa — Iowa City, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Corey J Keller, MD, PhD — Stanford University
- Study coordinator: Jade T Truong, BS
- Email: kellerlab@stanford.edu
- Phone: 408-840-3313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.