Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)
Stanford University
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged 18-65 years * Clinical diagnosis of Major Depressive Disorder (MDD), confirmed by structured clinical interview * Current moderate-to-severe depressive episode (MADRS score ≥ 20) * Moderate-to-severe treatment resistance, assessed using the Maudsley Staging Method * Able to comprehend English sufficiently to complete study procedures and assessments * Able to maintain stable antidepressant regimen or remain medication-free for at least 4 weeks prior to and during the study Exclusion Criteria: * Primary psychiatric diagnosis other than MDD * Contraindications to MR…
Interventions
- DevicePersonalized 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.
- DeviceNon-Personalized iTBS
Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold.
- DeviceSham iTBS
Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS.
Location
- Stanford UniversityStanford, California