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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH140799 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized iTBS | Experimental | Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker. |
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| Non-Personalized iTBS | Active Comparator | Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold). |
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| Sham iTBS | Sham Comparator | Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized iTBS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude | EL-TEP amplitude is the peak-to-trough amplitude of the early (20-60 ms) EEG response recorded over the left dorsolateral prefrontal cortex following single TMS pulses. Percent change is calculated from pre-iTBS to post-iTBS for each stimulation condition. | Baseline, end of 10 iTBS sessions within a single testing day (10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute EL-TEP Suppression Following Each Screened iTBS Condition | Percent change in EL-TEP amplitude from before to after each of the six screened iTBS parameter combinations during the screening phase. | Baseline, end of each iTBS session during the screening phase (3 screening days, up to approximately 3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jade T Truong, BS | Contact | (408) 831-2366 | kellerlab@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Corey J Keller, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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All participants receive all three arms.
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| Non-Personalized iTBS | Device | Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold. |
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| Sham iTBS | Device | Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS. |
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| Trajectory of EL-TEP Change Across Multiple Sessions Within a Testing Day |
EL-TEP amplitude measured before and after sessions 1, 2, 3, and 10 on each testing day to characterize cumulative effects. |
| 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 | Clinician-administered scale assessing depressive symptom severity. Score range: 0-60 (higher scores indicate greater severity). | Baseline, end of each testing day (up to approximately 7 weeks) |
| Change in Quick Inventory of Depressive Symptomatology (QIDS) Score | Self-report measure of depressive symptom severity. Score range: 0-27 (higher scores indicate greater severity). | Baseline, end of each testing day (up to approximately 7 weeks) |
| Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score | Self-report measure of anxiety symptom severity. Score range: 0-21 (higher scores indicate greater severity). | Baseline, end of each testing day (up to approximately 7 weeks) |
| Change in N-Back Task Performance | Working memory performance assessed using the N-back task. Outcome is accuracy and reaction time. | Baseline, end of each testing day (up to approximately 7 weeks) |
| Change in Multi-Source Interference Task (MSIT) Performance | Executive function assessed using the MSIT. Outcome is accuracy and reaction time. | Baseline, end of each testing day (up to approximately 7 weeks) |
| Change in Affective Processing Task Performance | Emotional face recognition task performance. Outcome is accuracy. | Baseline, end of each testing day (up to approximately 7 weeks) |