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NOT YET RECRUITING
NCT07528157
NA

Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.

Official title: Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-06-01

Completion Date

2027-12-31

Last Updated

2026-04-14

Healthy Volunteers

No

Interventions

DEVICE

Personalized iTBS

Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex using individualized pulse count (600, 1200, or 1800 pulses) and intensity (90% or 120% rMT) determined by EL-TEP screening.

DEVICE

Non-Personalized iTBS

Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold.

DEVICE

Sham iTBS

Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS.

Locations (1)

Stanford University

Stanford, California, United States