Personalized Brain Stimulation Guided by Brainwave Signals for Treatment-Resistant Depression
Compares personalized, standard and sham brain stimulation in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression
Key facts
- Where
- Stanford, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07528157, who can take part
Where in United States
- Stanford UniversityStanford, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stanford University
- Trial code
- NCT07528157
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)
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.
Inclusion: 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: Prior exposure to repetitive TMS (rTMS); Non-response to electroconvulsive therapy (ECT); Primary psychiatric diagnosis other than MDD; Conditions or medications that may increase risk associated with TMS; History of psychosurgery for depression; Contraindications to MRI (e.g., implanted metal); High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).