Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized iTBS, Non-Personalized iTBS, Sham iTBS.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder, Treatment Resistant Depression. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)
Overview
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.
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.
Primary outcome measures
- Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude [Time frame: Baseline, end of 10 iTBS sessions within a single testing day (10 hours)]
Secondary outcome measures (8)
- Acute EL-TEP Suppression Following Each Screened iTBS Condition [Time frame: Baseline, end of each iTBS session during the screening phase (3 screening days, up to approximately 3 weeks)]
- Trajectory of EL-TEP Change Across Multiple Sessions Within a Testing Day [Time frame: Baseline, before and after sessions 1, 2, 3, and 10 within a single testing day (10 hours)]
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
- Change in Quick Inventory of Depressive Symptomatology (QIDS) Score [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
- Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
- Change in N-Back Task Performance [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
- Change in Multi-Source Interference Task (MSIT) Performance [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
- Change in Affective Processing Task Performance [Time frame: Baseline, end of each testing day (up to approximately 7 weeks)]
Eligibility criteria
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 MRI (e.g., implanted metal)
- Conditions or medications that may increase risk associated with TMS
- Prior exposure to repetitive TMS (rTMS)
- Non-response to electroconvulsive therapy (ECT)
- History of psychosurgery for depression
- High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT07528157 · 85003-1 · R61MH140799