Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Primary psychiatric diagnosis other than MDD
Contraindications to MRI (e.g., implanted metal)
Conditions or medications that may increase risk associated with TMS
Prior exposure to repetitive TMS (rTMS)
Trial design
Treatments tested in this trial
- Personalized iTBS
- Non-Personalized iTBS
- Sham iTBS
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov